Trial Outcomes & Findings for A Study of TAK-951 in Healthy Adults (NCT NCT05567393)
NCT ID: NCT05567393
Last Updated: 2023-09-14
Results Overview
The laboratory parameters of chemistry, and hematology were assessed. Clinical laboratory tests included serum chemistry, hematology, and urinalysis. MAV criteria: Alanine aminotransferase(U/L) \>3xupper limit of normal(ULN); Albumin\<2.5g/dL,\<25g/L; Alkaline phosphatase (U/L)\>3 x ULN; Aspartate aminotransferase (U/L)\>3 x ULN; Bilirubin\>1.5mg/dL, \>34.2 µmol/L; Calcium\<8.0 mg/dL,LLN-\<2.0mmol/L, \>1.0mmol/L; Carbon dioxide \<8.0 (mmol/L); Chloride\<75 mmol/L,\>126 mmol/L; Creatinine\>177µmol/L; Gamma glutamyl transferase (U/L)\>2.0 mg/dL, \>3.0 x ULN; Glucose\<3 mmol/L,\>10 mmol/L; Potassium\<3.0 mmol/L \>5.5 mmol/L; Protein(g/L)\<0.8 x LLN \>1.2 x ULN; Sodium\<130mmol/L \>150mmol/L; Urea nitrogen \>10.7; Erythrocytes 10\^12erythrocytes/L) \<0.8 x LLN,\>1.2 x ULN; Hematocrit(%) \<0.8 x LLN,\>1.2xULN; Hemoglobin(g/L)\<0.8 x LLN, \>1.2 x ULN; Leukocytes(10\^9 leukocytes/L)\<0.5 x LLN \>1.5 x ULN; platelets(10\^9 platelets/L)\<75-\>600. Only categories with atleast one participant with event are reported.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
128 participants
Primary outcome timeframe
From the first dose of study drug up to follow-up or early termination (Up to approximately 32 days)
Results posted on
2023-09-14
Participant Flow
Participants took part in the study at 1 investigative site in the United States from 07 March 2019 to 02 November 2020.
Healthy participants were enrolled into Part 1 and Part 3 of this study. Participants were randomized into 12 cohorts in Part 1 to receive single-rising dose (SRD) and into 4 cohorts in Part 3 to receive multiple-rising doses (MRD) of TAK-951 or matching placebo in a 3:1 ratio. The randomization in Part 3 was based on the safe and tolerable doses determined in Part 1. As pre-specified in the protocol, Part 2 of the study was not conducted.
Participant milestones
| Measure |
Part 1 (SRD): Pooled Placebo
TAK-951 placebo-matching, single dose, subcutaneous (SC) injection, on Day 1 in fasted healthy participants in the single-rising dose (SRD) period.
|
Part 1 (SRD): Cohort 2: TAK-951 Dose 1
TAK-951 Dose 1, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 1: TAK-951 Dose 2
TAK-951 Dose 2, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 15: TAK-951 Dose 2
TAK-951 Dose 2, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 3: TAK-951 Dose 3
TAK-951 Dose 3, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 4: TAK-951 Dose 4
TAK-951 Dose 4, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 5: TAK-951 Dose 5
TAK-951 Dose 5, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 6: TAK-951 Dose 6
TAK-951 Dose 6, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 13: TAK-951 Dose 7
TAK-951 Dose 7, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 14: TAK-951 Dose 8
TAK-951 Dose 8, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 16: TAK-951 Dose 9
TAK-951 Dose 9, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 17: TAK-951 Dose 10
TAK-951 Dose 10, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 18: TAK-951 Dose 11
TAK-951 Dose 11, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 3 (MRD): Pooled Placebo
TAK-951 placebo-matching, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
Part 3 (MRD): Cohort 10: TAK-951 Dose 1A
TAK-951 Dose 1A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
Part 3 (MRD): Cohort 11: TAK-951 Dose 2A
TAK-951 Dose 2A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
Part 3 (MRD): Cohort 12: TAK-951 Dose 3A
TAK-951 Dose 3A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
Part 3 (MRD): Cohort 20: TAK-951 Dose 4A
TAK-951 Dose 4A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
24
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
8
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
24
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
7
|
6
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part 1 (SRD): Pooled Placebo
TAK-951 placebo-matching, single dose, subcutaneous (SC) injection, on Day 1 in fasted healthy participants in the single-rising dose (SRD) period.
|
Part 1 (SRD): Cohort 2: TAK-951 Dose 1
TAK-951 Dose 1, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 1: TAK-951 Dose 2
TAK-951 Dose 2, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 15: TAK-951 Dose 2
TAK-951 Dose 2, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 3: TAK-951 Dose 3
TAK-951 Dose 3, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 4: TAK-951 Dose 4
TAK-951 Dose 4, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 5: TAK-951 Dose 5
TAK-951 Dose 5, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 6: TAK-951 Dose 6
TAK-951 Dose 6, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 13: TAK-951 Dose 7
TAK-951 Dose 7, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 14: TAK-951 Dose 8
TAK-951 Dose 8, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 16: TAK-951 Dose 9
TAK-951 Dose 9, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 17: TAK-951 Dose 10
TAK-951 Dose 10, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 18: TAK-951 Dose 11
TAK-951 Dose 11, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 3 (MRD): Pooled Placebo
TAK-951 placebo-matching, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
Part 3 (MRD): Cohort 10: TAK-951 Dose 1A
TAK-951 Dose 1A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
Part 3 (MRD): Cohort 11: TAK-951 Dose 2A
TAK-951 Dose 2A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
Part 3 (MRD): Cohort 12: TAK-951 Dose 3A
TAK-951 Dose 3A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
Part 3 (MRD): Cohort 20: TAK-951 Dose 4A
TAK-951 Dose 4A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Voluntary Withdrawal
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study of TAK-951 in Healthy Adults
Baseline characteristics by cohort
| Measure |
Part 1 (SRD): Pooled Placebo
n=24 Participants
TAK-951 placebo-matching, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 2: TAK-951 Dose 1
n=6 Participants
TAK-951 Dose 1, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 1: TAK-951 Dose 2
n=6 Participants
TAK-951 Dose 2, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 15: TAK-951 Dose 2
n=6 Participants
TAK-951 Dose 2, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 3: TAK-951 Dose 3
n=6 Participants
TAK-951 Dose 3, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 4: TAK-951 Dose 4
n=6 Participants
TAK-951 Dose 4, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 5: TAK-951 Dose 5
n=6 Participants
TAK-951 Dose 5, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 6: TAK-951 Dose 6
n=6 Participants
TAK-951 Dose 6, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 13: TAK-951 Dose 7
n=6 Participants
TAK-951 Dose 7, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 14: TAK-951 Dose 8
n=6 Participants
TAK-951 Dose 8, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 16: TAK-951 Dose 9
n=6 Participants
TAK-951 Dose 9, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 17: TAK-951 Dose 10
n=6 Participants
TAK-951 Dose 10, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 18: TAK-951 Dose 11
n=6 Participants
TAK-951 Dose 11, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 3 (MRD): Pooled Placebo
n=8 Participants
TAK-951 placebo-matching, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
Part 3 (MRD): Cohort 10: TAK-951 Dose 1A
n=6 Participants
TAK-951 Dose 1A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
Part 3 (MRD): Cohort 11: TAK-951 Dose 2A
n=6 Participants
TAK-951 Dose 2A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
Part 3 (MRD): Cohort 12: TAK-951 Dose 3A
n=6 Participants
TAK-951 Dose 3A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
Part 3 (MRD): Cohort 20: TAK-951 Dose 4A
n=6 Participants
TAK-951 Dose 4A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
Total
n=128 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
39.4 years
n=5 Participants
|
35.2 years
n=7 Participants
|
40.0 years
n=5 Participants
|
35.5 years
n=4 Participants
|
41.8 years
n=21 Participants
|
35.2 years
n=10 Participants
|
34.8 years
n=115 Participants
|
32.0 years
n=6 Participants
|
38.7 years
n=6 Participants
|
42.2 years
n=64 Participants
|
34.5 years
n=17 Participants
|
27.8 years
n=21 Participants
|
43.0 years
n=22 Participants
|
37.3 years
n=8 Participants
|
35.2 years
n=16 Participants
|
33.2 years
n=135 Participants
|
41.3 years
n=136 Participants
|
40.3 years
n=44 Participants
|
37.4 years
n=667 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=22 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=16 Participants
|
1 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
11 Participants
n=667 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=64 Participants
|
6 Participants
n=17 Participants
|
6 Participants
n=21 Participants
|
5 Participants
n=22 Participants
|
7 Participants
n=8 Participants
|
5 Participants
n=16 Participants
|
5 Participants
n=135 Participants
|
6 Participants
n=136 Participants
|
6 Participants
n=44 Participants
|
117 Participants
n=667 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
3 Participants
n=64 Participants
|
3 Participants
n=17 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=22 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=16 Participants
|
0 Participants
n=135 Participants
|
4 Participants
n=136 Participants
|
2 Participants
n=44 Participants
|
36 Participants
n=667 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
5 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
3 Participants
n=64 Participants
|
3 Participants
n=17 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=22 Participants
|
4 Participants
n=8 Participants
|
4 Participants
n=16 Participants
|
6 Participants
n=135 Participants
|
2 Participants
n=136 Participants
|
4 Participants
n=44 Participants
|
91 Participants
n=667 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
1 Participants
n=667 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=16 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
6 Participants
n=667 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
1 Participants
n=17 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=22 Participants
|
4 Participants
n=8 Participants
|
2 Participants
n=16 Participants
|
1 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
3 Participants
n=44 Participants
|
41 Participants
n=667 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
3 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
5 Participants
n=64 Participants
|
3 Participants
n=17 Participants
|
3 Participants
n=21 Participants
|
5 Participants
n=22 Participants
|
4 Participants
n=8 Participants
|
3 Participants
n=16 Participants
|
4 Participants
n=135 Participants
|
5 Participants
n=136 Participants
|
3 Participants
n=44 Participants
|
69 Participants
n=667 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
4 Participants
n=667 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=64 Participants
|
2 Participants
n=17 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=16 Participants
|
1 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
8 Participants
n=667 Participants
|
|
Region of Enrollment
United States
|
24 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=64 Participants
|
6 Participants
n=17 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=22 Participants
|
8 Participants
n=8 Participants
|
6 Participants
n=16 Participants
|
6 Participants
n=135 Participants
|
6 Participants
n=136 Participants
|
6 Participants
n=44 Participants
|
128 Participants
n=667 Participants
|
|
Weight
|
81.20 kg
n=5 Participants
|
78.88 kg
n=7 Participants
|
81.45 kg
n=5 Participants
|
74.10 kg
n=4 Participants
|
73.27 kg
n=21 Participants
|
76.65 kg
n=10 Participants
|
80.02 kg
n=115 Participants
|
76.27 kg
n=6 Participants
|
81.27 kg
n=6 Participants
|
78.87 kg
n=64 Participants
|
77.88 kg
n=17 Participants
|
75.17 kg
n=21 Participants
|
74.92 kg
n=22 Participants
|
78.64 kg
n=8 Participants
|
77.68 kg
n=16 Participants
|
76.35 kg
n=135 Participants
|
75.73 kg
n=136 Participants
|
83.75 kg
n=44 Participants
|
77.89 kg
n=667 Participants
|
|
Height
|
176.8 cm
n=5 Participants
|
174.3 cm
n=7 Participants
|
175.7 cm
n=5 Participants
|
177.8 cm
n=4 Participants
|
174.5 cm
n=21 Participants
|
177.2 cm
n=10 Participants
|
182.5 cm
n=115 Participants
|
173.8 cm
n=6 Participants
|
175.5 cm
n=6 Participants
|
174.0 cm
n=64 Participants
|
174.0 cm
n=17 Participants
|
172.5 cm
n=21 Participants
|
175.8 cm
n=22 Participants
|
175.3 cm
n=8 Participants
|
172.0 cm
n=16 Participants
|
174.7 cm
n=135 Participants
|
169.3 cm
n=136 Participants
|
175.0 cm
n=44 Participants
|
175.04 cm
n=667 Participants
|
|
Body Mass Index (BMI)
|
25.99 kg/m^2
n=5 Participants
|
26.08 kg/m^2
n=7 Participants
|
26.32 kg/m^2
n=5 Participants
|
23.43 kg/m^2
n=4 Participants
|
23.90 kg/m^2
n=21 Participants
|
24.42 kg/m^2
n=10 Participants
|
23.88 kg/m^2
n=115 Participants
|
25.23 kg/m^2
n=6 Participants
|
26.43 kg/m^2
n=6 Participants
|
26.07 kg/m^2
n=64 Participants
|
25.77 kg/m^2
n=17 Participants
|
25.20 kg/m^2
n=21 Participants
|
24.25 kg/m^2
n=22 Participants
|
25.68 kg/m^2
n=8 Participants
|
26.17 kg/m^2
n=16 Participants
|
25.00 kg/m^2
n=135 Participants
|
26.32 kg/m^2
n=136 Participants
|
27.27 kg/m^2
n=44 Participants
|
25.41 kg/m^2
n=667 Participants
|
PRIMARY outcome
Timeframe: From the first dose of study drug up to follow-up or early termination (Up to approximately 32 days)Population: Safety Set included all randomized participants who received at least 1 dose of investigational products in each part of the study.
Physical examination included the examination of the abdomen; extremities; head, eyes, ears, nose (HEENT); neurological; skin and mucosae; thorax.
Outcome measures
| Measure |
Part 1 (SRD): Pooled Placebo
n=24 Participants
TAK-951 placebo-matching, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 2: TAK-951 Dose 1
n=6 Participants
TAK-951 Dose 1, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 1: TAK-951 Dose 2
n=6 Participants
TAK-951 Dose 2, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 15: TAK-951 Dose 2
n=6 Participants
TAK-951 Dose 2, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 3: TAK-951 Dose 3
n=6 Participants
TAK-951 Dose 3, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 4: TAK-951 Dose 4
n=6 Participants
TAK-951 Dose 4, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 5: TAK-951 Dose 5
n=6 Participants
TAK-951 Dose 5, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 6: TAK-951 Dose 6
n=6 Participants
TAK-951 Dose 6, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 13: TAK-951 Dose 7
n=6 Participants
TAK-951 Dose 7, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 14: TAK-951 Dose 8
n=6 Participants
TAK-951 Dose 8, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 16: TAK-951 Dose 9
n=6 Participants
TAK-951 Dose 9, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 17: TAK-951 Dose 10
n=6 Participants
TAK-951 Dose 10, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 18: TAK-951 Dose 11
n=6 Participants
TAK-951 Dose 11, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 3 (MRD): Pooled Placebo
n=8 Participants
TAK-951 placebo-matching, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
Part 3 (MRD): Cohort 10: TAK-951 Dose 1A
n=6 Participants
TAK-951 Dose 1A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
Part 3 (MRD): Cohort 11: TAK-951 Dose 2A
n=6 Participants
TAK-951 Dose 2A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
Part 3 (MRD): Cohort 12: TAK-951 Dose 3A
n=6 Participants
TAK-951 Dose 3A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
Part 3 (MRD): Cohort 20: TAK-951 Dose 4A
n=6 Participants
TAK-951 Dose 4A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Parts 1 and 3: Percentage of Participants With Clinically Significant Physical Examination Findings
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: From the first dose of study drug up to follow-up or early termination (Up to approximately 32 days)Population: Safety Set included all randomized participants who received at least 1 dose of investigational products in each part of the study. The values are rounded off to the nearest whole number.
The criteria for markedly abnormal values of vital signs' parameters were: Pulse Rate (beats/minute) \<50 and \>120; Systolic Blood Pressure \[millimeters of mercury (mmHg)\] \<85 and \>180; Diastolic Blood Pressure (mmHg) \<50 and \>110; Temperature \[degrees Celsius (C)\] \<35.6 and \>37.7. Only categories with atleast one participant with events are reported.
Outcome measures
| Measure |
Part 1 (SRD): Pooled Placebo
n=24 Participants
TAK-951 placebo-matching, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 2: TAK-951 Dose 1
n=6 Participants
TAK-951 Dose 1, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 1: TAK-951 Dose 2
n=6 Participants
TAK-951 Dose 2, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 15: TAK-951 Dose 2
n=6 Participants
TAK-951 Dose 2, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 3: TAK-951 Dose 3
n=6 Participants
TAK-951 Dose 3, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 4: TAK-951 Dose 4
n=6 Participants
TAK-951 Dose 4, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 5: TAK-951 Dose 5
n=6 Participants
TAK-951 Dose 5, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 6: TAK-951 Dose 6
n=6 Participants
TAK-951 Dose 6, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 13: TAK-951 Dose 7
n=6 Participants
TAK-951 Dose 7, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 14: TAK-951 Dose 8
n=6 Participants
TAK-951 Dose 8, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 16: TAK-951 Dose 9
n=6 Participants
TAK-951 Dose 9, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 17: TAK-951 Dose 10
n=6 Participants
TAK-951 Dose 10, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 18: TAK-951 Dose 11
n=6 Participants
TAK-951 Dose 11, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 3 (MRD): Pooled Placebo
n=8 Participants
TAK-951 placebo-matching, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
Part 3 (MRD): Cohort 10: TAK-951 Dose 1A
n=6 Participants
TAK-951 Dose 1A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
Part 3 (MRD): Cohort 11: TAK-951 Dose 2A
n=6 Participants
TAK-951 Dose 2A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
Part 3 (MRD): Cohort 12: TAK-951 Dose 3A
n=6 Participants
TAK-951 Dose 3A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
Part 3 (MRD): Cohort 20: TAK-951 Dose 4A
n=6 Participants
TAK-951 Dose 4A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Parts 1 and 3: Percentage of Participants With Markedly Abnormal Values of Vital Signs Parameters
Diastolic Blood Pressure (mmHg) <50
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
16.7 percentage of participants
|
33.3 percentage of participants
|
16.7 percentage of participants
|
16.7 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Parts 1 and 3: Percentage of Participants With Markedly Abnormal Values of Vital Signs Parameters
Pulse Rate (beats/minute) <50
|
8.3 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
16.7 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
50.0 percentage of participants
|
50.0 percentage of participants
|
50.0 percentage of participants
|
0 percentage of participants
|
33.3 percentage of participants
|
|
Parts 1 and 3: Percentage of Participants With Markedly Abnormal Values of Vital Signs Parameters
Pulse Rate (beats/minute) >120
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
33.3 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
16.7 percentage of participants
|
50.0 percentage of participants
|
50.0 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
50.0 percentage of participants
|
16.7 percentage of participants
|
16.7 percentage of participants
|
|
Parts 1 and 3: Percentage of Participants With Markedly Abnormal Values of Vital Signs Parameters
Systolic Blood Pressure (mmHg) <85
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
33.3 percentage of participants
|
16.7 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
33.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Parts 1 and 3: Percentage of Participants With Markedly Abnormal Values of Vital Signs Parameters
Temperature (C) <35.6
|
4.2 percentage of participants
|
33.3 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
16.7 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
25.0 percentage of participants
|
33.3 percentage of participants
|
16.7 percentage of participants
|
16.7 percentage of participants
|
16.7 percentage of participants
|
PRIMARY outcome
Timeframe: From the first dose of study drug up to follow-up or early termination (Up to approximately 32 days)Population: Safety Set included all randomized participants who received at least 1 dose of investigational products in each part of the study. The values are rounded off to the nearest whole number.
The criteria for markedly abnormal values of 12-lead ECG parameters were: ECG Mean Heart Rate (beats/min) \<50 beats per minute and \>120 beats per minute; PR Interval, Aggregate \[milliseconds (msec)\] \<=80 msec and \>=200 msec; QRS Duration, Aggregate (msec) \<=80 msec and \>=120 msec; QT Interval with Fridericia Correction Method (QTcF) Interval, Aggregate (msec) \>=500 msec or \>=30 msec change from Baseline and \>=450 msec. Only categories with atleast one participant with event are reported.
Outcome measures
| Measure |
Part 1 (SRD): Pooled Placebo
n=24 Participants
TAK-951 placebo-matching, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 2: TAK-951 Dose 1
n=6 Participants
TAK-951 Dose 1, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 1: TAK-951 Dose 2
n=6 Participants
TAK-951 Dose 2, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 15: TAK-951 Dose 2
n=6 Participants
TAK-951 Dose 2, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 3: TAK-951 Dose 3
n=6 Participants
TAK-951 Dose 3, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 4: TAK-951 Dose 4
n=6 Participants
TAK-951 Dose 4, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 5: TAK-951 Dose 5
n=6 Participants
TAK-951 Dose 5, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 6: TAK-951 Dose 6
n=6 Participants
TAK-951 Dose 6, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 13: TAK-951 Dose 7
n=6 Participants
TAK-951 Dose 7, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 14: TAK-951 Dose 8
n=6 Participants
TAK-951 Dose 8, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 16: TAK-951 Dose 9
n=6 Participants
TAK-951 Dose 9, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 17: TAK-951 Dose 10
n=6 Participants
TAK-951 Dose 10, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 18: TAK-951 Dose 11
n=6 Participants
TAK-951 Dose 11, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 3 (MRD): Pooled Placebo
n=8 Participants
TAK-951 placebo-matching, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
Part 3 (MRD): Cohort 10: TAK-951 Dose 1A
n=6 Participants
TAK-951 Dose 1A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
Part 3 (MRD): Cohort 11: TAK-951 Dose 2A
n=6 Participants
TAK-951 Dose 2A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
Part 3 (MRD): Cohort 12: TAK-951 Dose 3A
n=6 Participants
TAK-951 Dose 3A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
Part 3 (MRD): Cohort 20: TAK-951 Dose 4A
n=6 Participants
TAK-951 Dose 4A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Parts 1 and 3: Percentage of Participants With Markedly Abnormal Values of 12-Lead Electrocardiogram (ECG) Parameters
QRS Duration, Aggregate (msec) <=80
|
20.8 percentage of participants
|
16.7 percentage of participants
|
16.7 percentage of participants
|
16.7 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
33.3 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
16.7 percentage of participants
|
16.7 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
33.3 percentage of participants
|
16.7 percentage of participants
|
16.7 percentage of participants
|
|
Parts 1 and 3: Percentage of Participants With Markedly Abnormal Values of 12-Lead Electrocardiogram (ECG) Parameters
ECG Mean Heart Rate (beats/minute) <50
|
8.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
16.7 percentage of participants
|
33.3 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
37.5 percentage of participants
|
0 percentage of participants
|
33.3 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
|
Parts 1 and 3: Percentage of Participants With Markedly Abnormal Values of 12-Lead Electrocardiogram (ECG) Parameters
PR Interval, Aggregate (msec) >=200
|
4.2 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: From the first dose of study drug up to follow-up or early termination (Up to approximately 32 days)Population: Safety Set included all randomized participants who received at least 1 dose of investigational products in each part of the study.
The laboratory parameters of chemistry, and hematology were assessed. Clinical laboratory tests included serum chemistry, hematology, and urinalysis. MAV criteria: Alanine aminotransferase(U/L) \>3xupper limit of normal(ULN); Albumin\<2.5g/dL,\<25g/L; Alkaline phosphatase (U/L)\>3 x ULN; Aspartate aminotransferase (U/L)\>3 x ULN; Bilirubin\>1.5mg/dL, \>34.2 µmol/L; Calcium\<8.0 mg/dL,LLN-\<2.0mmol/L, \>1.0mmol/L; Carbon dioxide \<8.0 (mmol/L); Chloride\<75 mmol/L,\>126 mmol/L; Creatinine\>177µmol/L; Gamma glutamyl transferase (U/L)\>2.0 mg/dL, \>3.0 x ULN; Glucose\<3 mmol/L,\>10 mmol/L; Potassium\<3.0 mmol/L \>5.5 mmol/L; Protein(g/L)\<0.8 x LLN \>1.2 x ULN; Sodium\<130mmol/L \>150mmol/L; Urea nitrogen \>10.7; Erythrocytes 10\^12erythrocytes/L) \<0.8 x LLN,\>1.2 x ULN; Hematocrit(%) \<0.8 x LLN,\>1.2xULN; Hemoglobin(g/L)\<0.8 x LLN, \>1.2 x ULN; Leukocytes(10\^9 leukocytes/L)\<0.5 x LLN \>1.5 x ULN; platelets(10\^9 platelets/L)\<75-\>600. Only categories with atleast one participant with event are reported.
Outcome measures
| Measure |
Part 1 (SRD): Pooled Placebo
n=24 Participants
TAK-951 placebo-matching, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 2: TAK-951 Dose 1
n=6 Participants
TAK-951 Dose 1, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 1: TAK-951 Dose 2
n=6 Participants
TAK-951 Dose 2, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 15: TAK-951 Dose 2
n=6 Participants
TAK-951 Dose 2, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 3: TAK-951 Dose 3
n=6 Participants
TAK-951 Dose 3, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 4: TAK-951 Dose 4
n=6 Participants
TAK-951 Dose 4, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 5: TAK-951 Dose 5
n=6 Participants
TAK-951 Dose 5, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 6: TAK-951 Dose 6
n=6 Participants
TAK-951 Dose 6, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 13: TAK-951 Dose 7
n=6 Participants
TAK-951 Dose 7, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 14: TAK-951 Dose 8
n=6 Participants
TAK-951 Dose 8, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 16: TAK-951 Dose 9
n=6 Participants
TAK-951 Dose 9, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 17: TAK-951 Dose 10
n=6 Participants
TAK-951 Dose 10, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 18: TAK-951 Dose 11
n=6 Participants
TAK-951 Dose 11, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 3 (MRD): Pooled Placebo
n=8 Participants
TAK-951 placebo-matching, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
Part 3 (MRD): Cohort 10: TAK-951 Dose 1A
n=6 Participants
TAK-951 Dose 1A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
Part 3 (MRD): Cohort 11: TAK-951 Dose 2A
n=6 Participants
TAK-951 Dose 2A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
Part 3 (MRD): Cohort 12: TAK-951 Dose 3A
n=6 Participants
TAK-951 Dose 3A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
Part 3 (MRD): Cohort 20: TAK-951 Dose 4A
n=6 Participants
TAK-951 Dose 4A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Parts 1 and 3: Percentage of Participants With Markedly Abnormal Values of Laboratory Parameters
Calcium(mmol/L):Corrected Serum Calcium <LLN 8.0mg/dL;<LLN 2.0mmol/L;Ionized calcium<LLN 1.0mmol/L
|
0 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
|
Parts 1 and 3: Percentage of Participants With Markedly Abnormal Values of Laboratory Parameters
Glucose (mmol/L) >10
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Parts 1 and 3: Percentage of Participants With Markedly Abnormal Values of Laboratory Parameters
Urea Nitrogen (mmol/L) >10.7
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
12.5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: From the first dose of study drug up to follow-up or early termination (Up to approximately 32 days)Population: Safety Set included all randomized participants who received at least 1 dose of investigational products in each part of the study. The values are rounded off to the nearest whole number.
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE was defined as an adverse event which occurred on or after the first dose of study drug and no more than 30 days after the last dose of study drug.
Outcome measures
| Measure |
Part 1 (SRD): Pooled Placebo
n=24 Participants
TAK-951 placebo-matching, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 2: TAK-951 Dose 1
n=6 Participants
TAK-951 Dose 1, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 1: TAK-951 Dose 2
n=6 Participants
TAK-951 Dose 2, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 15: TAK-951 Dose 2
n=6 Participants
TAK-951 Dose 2, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 3: TAK-951 Dose 3
n=6 Participants
TAK-951 Dose 3, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 4: TAK-951 Dose 4
n=6 Participants
TAK-951 Dose 4, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 5: TAK-951 Dose 5
n=6 Participants
TAK-951 Dose 5, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 6: TAK-951 Dose 6
n=6 Participants
TAK-951 Dose 6, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 13: TAK-951 Dose 7
n=6 Participants
TAK-951 Dose 7, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 14: TAK-951 Dose 8
n=6 Participants
TAK-951 Dose 8, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 16: TAK-951 Dose 9
n=6 Participants
TAK-951 Dose 9, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 17: TAK-951 Dose 10
n=6 Participants
TAK-951 Dose 10, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 18: TAK-951 Dose 11
n=6 Participants
TAK-951 Dose 11, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 3 (MRD): Pooled Placebo
n=8 Participants
TAK-951 placebo-matching, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
Part 3 (MRD): Cohort 10: TAK-951 Dose 1A
n=6 Participants
TAK-951 Dose 1A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
Part 3 (MRD): Cohort 11: TAK-951 Dose 2A
n=6 Participants
TAK-951 Dose 2A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
Part 3 (MRD): Cohort 12: TAK-951 Dose 3A
n=6 Participants
TAK-951 Dose 3A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
Part 3 (MRD): Cohort 20: TAK-951 Dose 4A
n=6 Participants
TAK-951 Dose 4A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Parts 1 and 3: Percentage of Participants With Treatment-Emergent Adverse Events
|
16.7 percentage of participants
|
16.7 percentage of participants
|
16.7 percentage of participants
|
16.7 percentage of participants
|
16.7 percentage of participants
|
16.7 percentage of participants
|
33.3 percentage of participants
|
50.0 percentage of participants
|
50.0 percentage of participants
|
83.3 percentage of participants
|
66.7 percentage of participants
|
83.3 percentage of participants
|
33.3 percentage of participants
|
37.5 percentage of participants
|
16.7 percentage of participants
|
83.3 percentage of participants
|
66.7 percentage of participants
|
83.3 percentage of participants
|
PRIMARY outcome
Timeframe: From the first dose of study drug up to follow-up or early termination (Up to approximately 32 days)Population: Safety Set included all randomized participants who received at least 1 dose of investigational products in each part of the study.
Outcome measures
| Measure |
Part 1 (SRD): Pooled Placebo
n=24 Participants
TAK-951 placebo-matching, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 2: TAK-951 Dose 1
n=6 Participants
TAK-951 Dose 1, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 1: TAK-951 Dose 2
n=6 Participants
TAK-951 Dose 2, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 15: TAK-951 Dose 2
n=6 Participants
TAK-951 Dose 2, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 3: TAK-951 Dose 3
n=6 Participants
TAK-951 Dose 3, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 4: TAK-951 Dose 4
n=6 Participants
TAK-951 Dose 4, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 5: TAK-951 Dose 5
n=6 Participants
TAK-951 Dose 5, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 6: TAK-951 Dose 6
n=6 Participants
TAK-951 Dose 6, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 13: TAK-951 Dose 7
n=6 Participants
TAK-951 Dose 7, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 14: TAK-951 Dose 8
n=6 Participants
TAK-951 Dose 8, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 16: TAK-951 Dose 9
n=6 Participants
TAK-951 Dose 9, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 17: TAK-951 Dose 10
n=6 Participants
TAK-951 Dose 10, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 18: TAK-951 Dose 11
n=6 Participants
TAK-951 Dose 11, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 3 (MRD): Pooled Placebo
n=8 Participants
TAK-951 placebo-matching, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
Part 3 (MRD): Cohort 10: TAK-951 Dose 1A
n=6 Participants
TAK-951 Dose 1A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
Part 3 (MRD): Cohort 11: TAK-951 Dose 2A
n=6 Participants
TAK-951 Dose 2A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
Part 3 (MRD): Cohort 12: TAK-951 Dose 3A
n=6 Participants
TAK-951 Dose 3A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
Part 3 (MRD): Cohort 20: TAK-951 Dose 4A
n=6 Participants
TAK-951 Dose 4A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Parts 1 and 3: Percentage of Participants With Positive Immunogenicity (ADA) Status
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
16.7 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose in Part 1Population: Part 1: Pharmacokinetic (PK) Set included all participants who received TAK-951 and had at least 1 measurable plasma concentration of TAK-951 in Part 1.
Outcome measures
| Measure |
Part 1 (SRD): Pooled Placebo
n=6 Participants
TAK-951 placebo-matching, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 2: TAK-951 Dose 1
n=6 Participants
TAK-951 Dose 1, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 1: TAK-951 Dose 2
n=6 Participants
TAK-951 Dose 2, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 15: TAK-951 Dose 2
n=6 Participants
TAK-951 Dose 2, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 3: TAK-951 Dose 3
n=6 Participants
TAK-951 Dose 3, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 4: TAK-951 Dose 4
n=6 Participants
TAK-951 Dose 4, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 5: TAK-951 Dose 5
n=6 Participants
TAK-951 Dose 5, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 6: TAK-951 Dose 6
n=6 Participants
TAK-951 Dose 6, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 13: TAK-951 Dose 7
n=6 Participants
TAK-951 Dose 7, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 14: TAK-951 Dose 8
n=6 Participants
TAK-951 Dose 8, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 16: TAK-951 Dose 9
n=6 Participants
TAK-951 Dose 9, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 17: TAK-951 Dose 10
n=6 Participants
TAK-951 Dose 10, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 18: TAK-951 Dose 11
TAK-951 Dose 11, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 3 (MRD): Pooled Placebo
TAK-951 placebo-matching, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
Part 3 (MRD): Cohort 10: TAK-951 Dose 1A
TAK-951 Dose 1A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
Part 3 (MRD): Cohort 11: TAK-951 Dose 2A
TAK-951 Dose 2A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
Part 3 (MRD): Cohort 12: TAK-951 Dose 3A
TAK-951 Dose 3A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
Part 3 (MRD): Cohort 20: TAK-951 Dose 4A
TAK-951 Dose 4A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Cmax: Maximum Observed Plasma Concentration for TAK-951
|
177 picograms per milliliters (pg/mL)
Geometric Coefficient of Variation 22.3
|
213 picograms per milliliters (pg/mL)
Geometric Coefficient of Variation 35.4
|
420 picograms per milliliters (pg/mL)
Geometric Coefficient of Variation 14.4
|
383 picograms per milliliters (pg/mL)
Geometric Coefficient of Variation 20.0
|
717 picograms per milliliters (pg/mL)
Geometric Coefficient of Variation 29.0
|
2070 picograms per milliliters (pg/mL)
Geometric Coefficient of Variation 24.7
|
3010 picograms per milliliters (pg/mL)
Geometric Coefficient of Variation 38.4
|
4230 picograms per milliliters (pg/mL)
Geometric Coefficient of Variation 32.4
|
8920 picograms per milliliters (pg/mL)
Geometric Coefficient of Variation 41.7
|
8540 picograms per milliliters (pg/mL)
Geometric Coefficient of Variation 23.6
|
27900 picograms per milliliters (pg/mL)
Geometric Coefficient of Variation 19.3
|
54300 picograms per milliliters (pg/mL)
Geometric Coefficient of Variation 14.1
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose in Part 1Population: PK Set (Part 1) included all participants who received TAK-951 and had at least 1 measurable plasma concentration of TAK-951 in Part 1. Two participants were excluded from the overall number analyzed from 'Part 1 (SRD): Cohort 6: TAK-951 Dose 6' arm as their values were derived from poorly estimated elimination phase during the analysis.
Outcome measures
| Measure |
Part 1 (SRD): Pooled Placebo
n=6 Participants
TAK-951 placebo-matching, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 2: TAK-951 Dose 1
TAK-951 Dose 1, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 1: TAK-951 Dose 2
n=6 Participants
TAK-951 Dose 2, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 15: TAK-951 Dose 2
TAK-951 Dose 2, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 3: TAK-951 Dose 3
n=6 Participants
TAK-951 Dose 3, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 4: TAK-951 Dose 4
n=6 Participants
TAK-951 Dose 4, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 5: TAK-951 Dose 5
n=4 Participants
TAK-951 Dose 5, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 6: TAK-951 Dose 6
n=6 Participants
TAK-951 Dose 6, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 13: TAK-951 Dose 7
n=6 Participants
TAK-951 Dose 7, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 14: TAK-951 Dose 8
n=6 Participants
TAK-951 Dose 8, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 16: TAK-951 Dose 9
n=6 Participants
TAK-951 Dose 9, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 17: TAK-951 Dose 10
n=6 Participants
TAK-951 Dose 10, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 18: TAK-951 Dose 11
TAK-951 Dose 11, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 3 (MRD): Pooled Placebo
TAK-951 placebo-matching, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
Part 3 (MRD): Cohort 10: TAK-951 Dose 1A
TAK-951 Dose 1A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
Part 3 (MRD): Cohort 11: TAK-951 Dose 2A
TAK-951 Dose 2A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
Part 3 (MRD): Cohort 12: TAK-951 Dose 3A
TAK-951 Dose 3A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
Part 3 (MRD): Cohort 20: TAK-951 Dose 4A
TAK-951 Dose 4A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-951
|
813 picograms*hour per milliliters(pg*hr/mL)
Geometric Coefficient of Variation 14.6
|
—
|
1960 picograms*hour per milliliters(pg*hr/mL)
Geometric Coefficient of Variation 8.50
|
—
|
3920 picograms*hour per milliliters(pg*hr/mL)
Geometric Coefficient of Variation 12.3
|
9230 picograms*hour per milliliters(pg*hr/mL)
Geometric Coefficient of Variation 25.7
|
15300 picograms*hour per milliliters(pg*hr/mL)
Geometric Coefficient of Variation 14.0
|
21700 picograms*hour per milliliters(pg*hr/mL)
Geometric Coefficient of Variation 34.4
|
46700 picograms*hour per milliliters(pg*hr/mL)
Geometric Coefficient of Variation 23.3
|
50700 picograms*hour per milliliters(pg*hr/mL)
Geometric Coefficient of Variation 25.7
|
140000 picograms*hour per milliliters(pg*hr/mL)
Geometric Coefficient of Variation 17.8
|
340000 picograms*hour per milliliters(pg*hr/mL)
Geometric Coefficient of Variation 20.8
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and at multiple time points (up to 24 hours) post-dose on Day 1 in Part 3Population: PK Set (Part 3) included all participants who received TAK-951 and had at least 1 measurable plasma concentration of TAK-951 in Part 3.
Outcome measures
| Measure |
Part 1 (SRD): Pooled Placebo
n=6 Participants
TAK-951 placebo-matching, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 2: TAK-951 Dose 1
n=6 Participants
TAK-951 Dose 1, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 1: TAK-951 Dose 2
n=6 Participants
TAK-951 Dose 2, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 15: TAK-951 Dose 2
n=6 Participants
TAK-951 Dose 2, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 3: TAK-951 Dose 3
TAK-951 Dose 3, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 4: TAK-951 Dose 4
TAK-951 Dose 4, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 5: TAK-951 Dose 5
TAK-951 Dose 5, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 6: TAK-951 Dose 6
TAK-951 Dose 6, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 13: TAK-951 Dose 7
TAK-951 Dose 7, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 14: TAK-951 Dose 8
TAK-951 Dose 8, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 16: TAK-951 Dose 9
TAK-951 Dose 9, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 17: TAK-951 Dose 10
TAK-951 Dose 10, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 18: TAK-951 Dose 11
TAK-951 Dose 11, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 3 (MRD): Pooled Placebo
TAK-951 placebo-matching, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
Part 3 (MRD): Cohort 10: TAK-951 Dose 1A
TAK-951 Dose 1A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
Part 3 (MRD): Cohort 11: TAK-951 Dose 2A
TAK-951 Dose 2A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
Part 3 (MRD): Cohort 12: TAK-951 Dose 3A
TAK-951 Dose 3A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
Part 3 (MRD): Cohort 20: TAK-951 Dose 4A
TAK-951 Dose 4A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 3: Cmax: Maximum Observed Plasma Concentration for TAK-951 on Day 1
|
1260 pg/mL
Geometric Coefficient of Variation 27.1
|
6010 pg/mL
Geometric Coefficient of Variation 18.2
|
22400 pg/mL
Geometric Coefficient of Variation 25.8
|
33700 pg/mL
Geometric Coefficient of Variation 24.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose and at multiple time points (up to 24 hours) post-dose on Day 1 in Part 3Population: PK Set (Part 3) included all participants who received TAK-951 and had at least 1 measurable plasma concentration of TAK-951 in Part 3.
Outcome measures
| Measure |
Part 1 (SRD): Pooled Placebo
n=6 Participants
TAK-951 placebo-matching, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 2: TAK-951 Dose 1
n=6 Participants
TAK-951 Dose 1, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 1: TAK-951 Dose 2
n=6 Participants
TAK-951 Dose 2, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 15: TAK-951 Dose 2
n=6 Participants
TAK-951 Dose 2, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 3: TAK-951 Dose 3
TAK-951 Dose 3, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 4: TAK-951 Dose 4
TAK-951 Dose 4, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 5: TAK-951 Dose 5
TAK-951 Dose 5, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 6: TAK-951 Dose 6
TAK-951 Dose 6, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 13: TAK-951 Dose 7
TAK-951 Dose 7, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 14: TAK-951 Dose 8
TAK-951 Dose 8, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 16: TAK-951 Dose 9
TAK-951 Dose 9, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 17: TAK-951 Dose 10
TAK-951 Dose 10, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 18: TAK-951 Dose 11
TAK-951 Dose 11, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 3 (MRD): Pooled Placebo
TAK-951 placebo-matching, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
Part 3 (MRD): Cohort 10: TAK-951 Dose 1A
TAK-951 Dose 1A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
Part 3 (MRD): Cohort 11: TAK-951 Dose 2A
TAK-951 Dose 2A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
Part 3 (MRD): Cohort 12: TAK-951 Dose 3A
TAK-951 Dose 3A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
Part 3 (MRD): Cohort 20: TAK-951 Dose 4A
TAK-951 Dose 4A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part 3: AUCτ: Area Under the Plasma Concentration-time Curve During a Dosing Interval Tau (τ), From Time of First Daily Dose to 8 Hours for TAK-951 on Day 1
|
5420 pg*hr/mL
Geometric Coefficient of Variation 25.2
|
25000 pg*hr/mL
Geometric Coefficient of Variation 15.9
|
98100 pg*hr/mL
Geometric Coefficient of Variation 22.8
|
152000 pg*hr/mL
Geometric Coefficient of Variation 29.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Part 3 (MRD): Cohort 11: TAK-951 Dose 2A
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 3 (MRD): Cohort 12: TAK-951 Dose 3A
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 3 (MRD): Cohort 20: TAK-951 Dose 4A
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 1 (SRD): Pooled Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part 1 (SRD): Cohort 2: TAK-951 Dose 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1 (SRD): Cohort 1: TAK-951 Dose 2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1 (SRD): Cohort 15: TAK-951 Dose 2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1 (SRD): Cohort 3: TAK-951 Dose 3
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1 (SRD): Cohort 4: TAK-951 Dose 4
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part 1 (SRD): Cohort 5: TAK-951 Dose 5
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 1 (SRD): Cohort 6: TAK-951 Dose 6
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1 (SRD): Cohort 13: TAK-951 Dose 7
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 1 (SRD): Cohort 14: TAK-951 Dose 8
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 1 (SRD): Cohort 16: TAK-951 Dose 9
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part 1 (SRD): Cohort 17: TAK-951 Dose 10
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part 1 (SRD): Cohort 18: TAK-951 Dose 11
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part 3 (MRD): Pooled Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part 3 (MRD): Cohort 10: TAK-951 Dose 1A
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part 3 (MRD): Cohort 11: TAK-951 Dose 2A
n=6 participants at risk
TAK-951 Dose 2A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
Part 3 (MRD): Cohort 12: TAK-951 Dose 3A
n=6 participants at risk
TAK-951 Dose 3A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
Part 3 (MRD): Cohort 20: TAK-951 Dose 4A
n=6 participants at risk
TAK-951 Dose 4A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
Part 1 (SRD): Pooled Placebo
n=24 participants at risk
TAK-951 placebo-matching, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 2: TAK-951 Dose 1
n=6 participants at risk
TAK-951 Dose 1, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 1: TAK-951 Dose 2
n=6 participants at risk
TAK-951 Dose 2, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 15: TAK-951 Dose 2
n=6 participants at risk
TAK-951 Dose 2, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 3: TAK-951 Dose 3
n=6 participants at risk
TAK-951 Dose 3, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 4: TAK-951 Dose 4
n=6 participants at risk
TAK-951 Dose 4, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 5: TAK-951 Dose 5
n=6 participants at risk
TAK-951 Dose 5, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 6: TAK-951 Dose 6
n=6 participants at risk
TAK-951 Dose 6, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 13: TAK-951 Dose 7
n=6 participants at risk
TAK-951 Dose 7, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 14: TAK-951 Dose 8
n=6 participants at risk
TAK-951 Dose 8, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 16: TAK-951 Dose 9
n=6 participants at risk
TAK-951 Dose 9, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 17: TAK-951 Dose 10
n=6 participants at risk
TAK-951 Dose 10, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 18: TAK-951 Dose 11
n=6 participants at risk
TAK-951 Dose 11, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 3 (MRD): Pooled Placebo
n=8 participants at risk
TAK-951 placebo-matching, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
Part 3 (MRD): Cohort 10: TAK-951 Dose 1A
n=6 participants at risk
TAK-951 Dose 1A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Ventricular tachycardia
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Other adverse events
| Measure |
Part 3 (MRD): Cohort 11: TAK-951 Dose 2A
n=6 participants at risk
TAK-951 Dose 2A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
Part 3 (MRD): Cohort 12: TAK-951 Dose 3A
n=6 participants at risk
TAK-951 Dose 3A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
Part 3 (MRD): Cohort 20: TAK-951 Dose 4A
n=6 participants at risk
TAK-951 Dose 4A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
Part 1 (SRD): Pooled Placebo
n=24 participants at risk
TAK-951 placebo-matching, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 2: TAK-951 Dose 1
n=6 participants at risk
TAK-951 Dose 1, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 1: TAK-951 Dose 2
n=6 participants at risk
TAK-951 Dose 2, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 15: TAK-951 Dose 2
n=6 participants at risk
TAK-951 Dose 2, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 3: TAK-951 Dose 3
n=6 participants at risk
TAK-951 Dose 3, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 4: TAK-951 Dose 4
n=6 participants at risk
TAK-951 Dose 4, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 5: TAK-951 Dose 5
n=6 participants at risk
TAK-951 Dose 5, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 6: TAK-951 Dose 6
n=6 participants at risk
TAK-951 Dose 6, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 13: TAK-951 Dose 7
n=6 participants at risk
TAK-951 Dose 7, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 14: TAK-951 Dose 8
n=6 participants at risk
TAK-951 Dose 8, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 16: TAK-951 Dose 9
n=6 participants at risk
TAK-951 Dose 9, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 17: TAK-951 Dose 10
n=6 participants at risk
TAK-951 Dose 10, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 1 (SRD): Cohort 18: TAK-951 Dose 11
n=6 participants at risk
TAK-951 Dose 11, single dose, SC injection, on Day 1 in fasted healthy participants in the SRD period.
|
Part 3 (MRD): Pooled Placebo
n=8 participants at risk
TAK-951 placebo-matching, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
Part 3 (MRD): Cohort 10: TAK-951 Dose 1A
n=6 participants at risk
TAK-951 Dose 1A, SC injection, for 5 days from Days 1 to 5 in fasted healthy participants in the MRD period.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Fatigue
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Accelerated idioventricular rhythm
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Asthenia
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Bradyphrenia
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Chills
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
2/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
2/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
2/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Dizziness
|
33.3%
2/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
2/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
25.0%
2/8 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Dizziness postural
|
33.3%
2/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Feeling hot
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
2/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Hot flush
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Injection site bruising
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Injection site induration
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Injection site pain
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Injection site reaction
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
2/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
2/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Vascular disorders
Orthostatic hypotension
|
33.3%
2/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
2/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Palpitations
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
2/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Papule
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Peripheral swelling
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Postural orthostatic tachycardia syndrome
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
33.3%
2/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
12.5%
1/8 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Vessel puncture site bruise
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Eye disorders
Visual impairment
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/24 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/8 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • From first dose of study drug and up to 30 days post last dose (Parts 1 and 3: Up to approximately 32 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER