Trial Outcomes & Findings for A Study of TAK-994 in Adults With Type 1 and Type 2 Narcolepsy (NCT NCT04096560)
NCT ID: NCT04096560
Last Updated: 2024-10-29
Results Overview
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 is defined as an AE with an onset that occurs after receiving study drug.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
97 participants
Primary outcome timeframe
First dose of study treatment to end of study follow-up (up to Day 35) in Part A
Results posted on
2024-10-29
Participant Flow
Participants took part in the study at 35 investigative sites in Canada, China, France, Hungary, Italy, Japan, South Korea, Spain and United States from 27 May 2020 to 05 November 2021. The study was early terminated due to a safety signal that had emerged in the phase 2 studies of firazorexton.
Participants with Narcolepsy Type 1 or Type 2 were planned to be enrolled in study in Parts A, B, C and D to receive TAK-994 or placebo. Due to the early termination of the study, data was not collected for Part C: placebo and was insufficient for Part C: TAK-994 180 mg to allow the pre-planned analyses. Similarly, for Part D, the prespecified sample size at Week 4 was not reached and therefore the pre-planned analyses cannot be adequately interpreted.
Participant milestones
| Measure |
Part A: Placebo
TAK-994 placebo-matching tablets, orally, twice daily (BID) for 28 days, in participants with NT1.
|
Part A: TAK-994 120 mg
TAK-994 120 mg, orally, BID for 28 days, in participants with NT1.
|
Part A: TAK-994 180 mg
TAK-994 180 mg, orally, BID for 28 days, in participants with NT1.
|
Part B: Placebo
TAK-994 placebo-matching tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: TAK-994 30 mg
TAK-994 30 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: TAK-994 90 mg
TAK-994 90 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: TAK-994 180 mg
TAK-994 180 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part C: TAK-994 180 mg
TAK-994 180 mg tablets, orally, BID for 56 days, in Chinese participants with NT1.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
7
|
8
|
17
|
17
|
20
|
19
|
2
|
|
Overall Study
COMPLETED
|
6
|
7
|
8
|
12
|
10
|
12
|
9
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
5
|
7
|
8
|
10
|
2
|
Reasons for withdrawal
| Measure |
Part A: Placebo
TAK-994 placebo-matching tablets, orally, twice daily (BID) for 28 days, in participants with NT1.
|
Part A: TAK-994 120 mg
TAK-994 120 mg, orally, BID for 28 days, in participants with NT1.
|
Part A: TAK-994 180 mg
TAK-994 180 mg, orally, BID for 28 days, in participants with NT1.
|
Part B: Placebo
TAK-994 placebo-matching tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: TAK-994 30 mg
TAK-994 30 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: TAK-994 90 mg
TAK-994 90 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: TAK-994 180 mg
TAK-994 180 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part C: TAK-994 180 mg
TAK-994 180 mg tablets, orally, BID for 56 days, in Chinese participants with NT1.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Reason not Specified
|
1
|
0
|
0
|
0
|
1
|
1
|
1
|
0
|
|
Overall Study
Pretreatment Event, Serious Adverse Event, or Adverse Event
|
0
|
0
|
0
|
0
|
0
|
3
|
3
|
0
|
|
Overall Study
Study Terminated by Sponsor
|
0
|
0
|
0
|
5
|
6
|
4
|
6
|
1
|
|
Overall Study
Met the Discontinuation Criteria of the Protocol
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Due to early termination of the study, no secondary efficacy data was collected and analyzed for participants in Part C: TAK-994 180 mg.
Baseline characteristics by cohort
| Measure |
Part A: Placebo
n=7 Participants
TAK-994 placebo-matching tablets, orally, BID for 28 days, in participants with NT1.
|
Part A: TAK-994 120 mg
n=7 Participants
TAK-994 120 mg, orally, BID for 28 days, in participants with NT1.
|
Part A: TAK-994 180 mg
n=8 Participants
TAK-994 120 mg, orally, BID for 28 days, in participants with NT1
|
Part B: Placebo
n=17 Participants
TAK-994 placebo-matching tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: TAK-994 30 mg
n=17 Participants
TAK-994 30 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: TAK-994 90 mg
n=20 Participants
TAK-994 90 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: TAK-994 180 mg
n=19 Participants
TAK-994 180 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part C: TAK-994 180 mg
n=2 Participants
TAK-994 180 mg tablets, orally, BID for 56 days, in Chinese participants with NT1.
|
Total
n=97 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
31.4 years
n=7 Participants
|
38.0 years
n=7 Participants
|
33.4 years
n=8 Participants
|
32.6 years
n=17 Participants
|
33.4 years
n=17 Participants
|
28.8 years
n=20 Participants
|
29.2 years
n=19 Participants
|
38.5 years
n=2 Participants
|
33.16 years
n=97 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=7 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=8 Participants
|
8 Participants
n=17 Participants
|
12 Participants
n=17 Participants
|
10 Participants
n=20 Participants
|
12 Participants
n=19 Participants
|
1 Participants
n=2 Participants
|
54 Participants
n=97 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=7 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=8 Participants
|
9 Participants
n=17 Participants
|
5 Participants
n=17 Participants
|
10 Participants
n=20 Participants
|
7 Participants
n=19 Participants
|
1 Participants
n=2 Participants
|
43 Participants
n=97 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=17 Participants
|
2 Participants
n=17 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=2 Participants
|
2 Participants
n=97 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=7 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=8 Participants
|
17 Participants
n=17 Participants
|
14 Participants
n=17 Participants
|
19 Participants
n=20 Participants
|
18 Participants
n=19 Participants
|
2 Participants
n=2 Participants
|
92 Participants
n=97 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=17 Participants
|
1 Participants
n=17 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=19 Participants
|
0 Participants
n=2 Participants
|
3 Participants
n=97 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=97 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=8 Participants
|
1 Participants
n=17 Participants
|
6 Participants
n=17 Participants
|
6 Participants
n=20 Participants
|
3 Participants
n=19 Participants
|
2 Participants
n=2 Participants
|
24 Participants
n=97 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=97 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=7 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=17 Participants
|
1 Participants
n=17 Participants
|
4 Participants
n=20 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=2 Participants
|
12 Participants
n=97 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=7 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=8 Participants
|
11 Participants
n=17 Participants
|
7 Participants
n=17 Participants
|
8 Participants
n=20 Participants
|
15 Participants
n=19 Participants
|
0 Participants
n=2 Participants
|
52 Participants
n=97 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=17 Participants
|
1 Participants
n=17 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=2 Participants
|
2 Participants
n=97 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=7 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=17 Participants
|
2 Participants
n=17 Participants
|
2 Participants
n=20 Participants
|
1 Participants
n=19 Participants
|
0 Participants
n=2 Participants
|
7 Participants
n=97 Participants
|
|
Height
|
168.07 centimeters (cm)
n=7 Participants
|
176.61 centimeters (cm)
n=7 Participants
|
164.01 centimeters (cm)
n=8 Participants
|
171.00 centimeters (cm)
n=17 Participants
|
164.24 centimeters (cm)
n=17 Participants
|
168.38 centimeters (cm)
n=20 Participants
|
171.66 centimeters (cm)
n=19 Participants
|
169 centimeters (cm)
n=2 Participants
|
169.12 centimeters (cm)
n=97 Participants
|
|
Weight
|
85.77 kilograms (kg)
n=7 Participants
|
80.07 kilograms (kg)
n=7 Participants
|
74.33 kilograms (kg)
n=8 Participants
|
80.75 kilograms (kg)
n=17 Participants
|
71.97 kilograms (kg)
n=17 Participants
|
77.68 kilograms (kg)
n=20 Participants
|
80.33 kilograms (kg)
n=19 Participants
|
77 kilograms (kg)
n=2 Participants
|
78.48 kilograms (kg)
n=97 Participants
|
|
Body Mass Index (BMI)
|
30.529 kilogram per square meter (kg/m^2)
n=7 Participants
|
25.629 kilogram per square meter (kg/m^2)
n=7 Participants
|
27.575 kilogram per square meter (kg/m^2)
n=8 Participants
|
27.48 kilogram per square meter (kg/m^2)
n=17 Participants
|
26.56 kilogram per square meter (kg/m^2)
n=17 Participants
|
27.29 kilogram per square meter (kg/m^2)
n=20 Participants
|
27.21 kilogram per square meter (kg/m^2)
n=19 Participants
|
26.75 kilogram per square meter (kg/m^2)
n=2 Participants
|
27.37 kilogram per square meter (kg/m^2)
n=97 Participants
|
|
Average Sleep Latency (MWT)
|
3.30 minutes
n=7 Participants
|
4.41 minutes
n=7 Participants
|
2.75 minutes
n=8 Participants
|
6.0 minutes
n=17 Participants
|
6.1 minutes
n=17 Participants
|
6.1 minutes
n=20 Participants
|
4.9 minutes
n=19 Participants
|
17.87 minutes
n=2 Participants
|
6.43 minutes
n=97 Participants
|
|
Epworth Sleepiness Scale (ESS) Score
|
18.6 score on a scale
n=7 Participants
|
17.4 score on a scale
n=7 Participants
|
18.0 score on a scale
n=8 Participants
|
16.6 score on a scale
n=17 Participants
|
18.5 score on a scale
n=17 Participants
|
17.5 score on a scale
n=20 Participants
|
17.4 score on a scale
n=19 Participants
|
20 score on a scale
n=2 Participants
|
18 score on a scale
n=97 Participants
|
|
Weekly Cataplexy Rate (WCR)
|
19.9 cataplexy attacks per week
n=7 Participants • Due to early termination of the study, no secondary efficacy data was collected and analyzed for participants in Part C: TAK-994 180 mg.
|
19.1 cataplexy attacks per week
n=7 Participants • Due to early termination of the study, no secondary efficacy data was collected and analyzed for participants in Part C: TAK-994 180 mg.
|
12.0 cataplexy attacks per week
n=8 Participants • Due to early termination of the study, no secondary efficacy data was collected and analyzed for participants in Part C: TAK-994 180 mg.
|
15.94 cataplexy attacks per week
n=17 Participants • Due to early termination of the study, no secondary efficacy data was collected and analyzed for participants in Part C: TAK-994 180 mg.
|
14.98 cataplexy attacks per week
n=17 Participants • Due to early termination of the study, no secondary efficacy data was collected and analyzed for participants in Part C: TAK-994 180 mg.
|
11.68 cataplexy attacks per week
n=20 Participants • Due to early termination of the study, no secondary efficacy data was collected and analyzed for participants in Part C: TAK-994 180 mg.
|
15.37 cataplexy attacks per week
n=19 Participants • Due to early termination of the study, no secondary efficacy data was collected and analyzed for participants in Part C: TAK-994 180 mg.
|
—
|
13.62 cataplexy attacks per week
n=95 Participants • Due to early termination of the study, no secondary efficacy data was collected and analyzed for participants in Part C: TAK-994 180 mg.
|
PRIMARY outcome
Timeframe: First dose of study treatment to end of study follow-up (up to Day 35) in Part APopulation: Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
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 is defined as an AE with an onset that occurs after receiving study drug.
Outcome measures
| Measure |
Part B: FTAK-994 90 mg
n=8 Participants
TAK-994 90 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: TAK-994 180 mg
TAK-994 180 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part C: TAK-994 180 mg
TAK-994 180 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: Placebo
n=7 Participants
TAK-994 placebo-matching tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: TAK-994 30 mg
n=7 Participants
TAK-994 30 mg tablets, orally, BID for 56 days, in participants with NT1.
|
|---|---|---|---|---|---|
|
Part A: Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) During the Study
|
7 Participants
|
—
|
—
|
2 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: First dose of study treatment to end of study follow-up (up to Day 35) in Part APopulation: Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
Standard safety laboratory values (hematology, serum chemistry, urinalysis) were collected and compared to pre-specified criteria for markedly abnormal values. Markedly abnormal values criteria: Erythrocytes(10\^12/L:\<0.8xlower limit of normal(LLN), \>1.2xupper limit of normal(ULN); Hemoglobin grams per litre(g/L):\<0.8xLLN, \>1.2xULN; Hematocrit voltage/volts(V/V):\<0.8xLLN, \>1.2xULN; Platelets(10\^9/L):\<75, \>600; Leukocytes(10\^9/L):\<0.5xLLN, \>1.5xULN; Alanine Aminotransferase units/litre(U/L):\>3xULN, Aspartate Aminotransferase(U/L):\>3xULN; Bilirubin micromoles/litre (umol/L):\>1.5xULN; Alkaline Phosphatase(U/L):\>3xULN; Gamma Glutamyl Transferase(U/L):\>3 x ULN; Albumin(g/L):\<25; Protein Total(g/L):\<0.8xLLN, \>1.2xULN;Glucose millimoles/litre(mmol/L):\<2.8, \>19.4; Calcium(mmol/L):\<1.92, \>2.77; Creatinine(umol/L):\>1.5xULN; Urea(mmol/L):\>10.7; Sodium(mmol/L):\<130, \>150; Potassium(mmol/L):\<3.0, \>5.3. Only categories with at least one participant with event are reported.
Outcome measures
| Measure |
Part B: FTAK-994 90 mg
n=8 Participants
TAK-994 90 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: TAK-994 180 mg
TAK-994 180 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part C: TAK-994 180 mg
TAK-994 180 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: Placebo
n=7 Participants
TAK-994 placebo-matching tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: TAK-994 30 mg
n=7 Participants
TAK-994 30 mg tablets, orally, BID for 56 days, in participants with NT1.
|
|---|---|---|---|---|---|
|
Part A: Number of Participants Who Meet the Markedly Abnormal Value Criteria for Safety Laboratory Tests at Least Once Postdose During the Study
Calcium (mmol/L): <1.92
|
0 Participants
|
—
|
—
|
0 Participants
|
1 Participants
|
|
Part A: Number of Participants Who Meet the Markedly Abnormal Value Criteria for Safety Laboratory Tests at Least Once Postdose During the Study
Sodium (mmol/L): <130
|
0 Participants
|
—
|
—
|
0 Participants
|
1 Participants
|
|
Part A: Number of Participants Who Meet the Markedly Abnormal Value Criteria for Safety Laboratory Tests at Least Once Postdose During the Study
Potassium (mmol/L): >5.3
|
0 Participants
|
—
|
—
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: First dose of study treatment to end of study follow-up (up to Day 35) in Part APopulation: Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
Vital signs (body temperature and sitting blood pressure) were collected and compared to pre-specified criteria for markedly abnormal values throughout the study. Markedly abnormal values criteria: Heart Rate (beats/min): \<40, \>115; Systolic Blood Pressure millimeters of mercury (mmHg): \<90, ≥160, Change from Pre-Dose \>20, Change from Pre-Dose \>30, Time-matched Change from Baseline \> 20, Time-matched Change from Baseline \> 30; Diastolic Blood Pressure (mmHg): \<50, ≥100, Change from Pre-Dose \>20, Change from Pre-Dose \>30, Time-matched Change from Baseline \> 20, Time-matched Change from Baseline \> 30; Respiratory Rate (breaths/min): \>21; Temperature Celsius (C): \>38.5. Only categories with at least one participant with event are reported.
Outcome measures
| Measure |
Part B: FTAK-994 90 mg
n=8 Participants
TAK-994 90 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: TAK-994 180 mg
TAK-994 180 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part C: TAK-994 180 mg
TAK-994 180 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: Placebo
n=7 Participants
TAK-994 placebo-matching tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: TAK-994 30 mg
n=7 Participants
TAK-994 30 mg tablets, orally, BID for 56 days, in participants with NT1.
|
|---|---|---|---|---|---|
|
Part A: Number of Participants Who Meet the Markedly Abnormal Value Criteria for Vital Sign Measurements at Least Once Postdose During the Study
Systolic Blood Pressure (mmHg) <90
|
0 Participants
|
—
|
—
|
2 Participants
|
0 Participants
|
|
Part A: Number of Participants Who Meet the Markedly Abnormal Value Criteria for Vital Sign Measurements at Least Once Postdose During the Study
Systolic Blood Pressure (mmHg): Change from Pre-Dose >20
|
2 Participants
|
—
|
—
|
2 Participants
|
3 Participants
|
|
Part A: Number of Participants Who Meet the Markedly Abnormal Value Criteria for Vital Sign Measurements at Least Once Postdose During the Study
Systolic Blood Pressure (mmHg): Change from Pre-Dose >30
|
0 Participants
|
—
|
—
|
1 Participants
|
1 Participants
|
|
Part A: Number of Participants Who Meet the Markedly Abnormal Value Criteria for Vital Sign Measurements at Least Once Postdose During the Study
Systolic Blood Pressure (mmHg): Time-matched Change from Baseline > 20
|
6 Participants
|
—
|
—
|
4 Participants
|
7 Participants
|
|
Part A: Number of Participants Who Meet the Markedly Abnormal Value Criteria for Vital Sign Measurements at Least Once Postdose During the Study
Systolic Blood Pressure (mmHg): Time-matched Change from Baseline > 30
|
0 Participants
|
—
|
—
|
0 Participants
|
3 Participants
|
|
Part A: Number of Participants Who Meet the Markedly Abnormal Value Criteria for Vital Sign Measurements at Least Once Postdose During the Study
Diastolic blood pressure (mmHg): Change from Pre-Dose >20
|
0 Participants
|
—
|
—
|
1 Participants
|
3 Participants
|
|
Part A: Number of Participants Who Meet the Markedly Abnormal Value Criteria for Vital Sign Measurements at Least Once Postdose During the Study
Diastolic blood pressure (mmHg): Time-matched Change from Baseline > 20
|
3 Participants
|
—
|
—
|
1 Participants
|
4 Participants
|
|
Part A: Number of Participants Who Meet the Markedly Abnormal Value Criteria for Vital Sign Measurements at Least Once Postdose During the Study
Temperature (C): >38.5
|
0 Participants
|
—
|
—
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: First dose of study treatment to end of study follow-up (up to Day 35) in Part APopulation: Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
A 12 lead ECG was performed, the ECG values were compared to pre-specified criteria for markedly abnormal values. Markedly abnormal values criteria: ECG Mean Heart Rate (beats/min): \<40, \>115; PR Interval milliseconds (msec): ≤80, ≥200; corrected QT interval by Fredericia (QTcF) Interval (msec): ≤300, \>500, ≥30 change from baseline and \>450; QRS Duration (msec): ≤80, ≥180. Only categories with at least one participant with event are reported.
Outcome measures
| Measure |
Part B: FTAK-994 90 mg
n=8 Participants
TAK-994 90 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: TAK-994 180 mg
TAK-994 180 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part C: TAK-994 180 mg
TAK-994 180 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: Placebo
n=7 Participants
TAK-994 placebo-matching tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: TAK-994 30 mg
n=7 Participants
TAK-994 30 mg tablets, orally, BID for 56 days, in participants with NT1.
|
|---|---|---|---|---|---|
|
Part A: Number of Participants Who Meet the Markedly Abnormal Value Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Postdose During the Study
PR Interval (msec): ≥200
|
2 Participants
|
—
|
—
|
0 Participants
|
1 Participants
|
|
Part A: Number of Participants Who Meet the Markedly Abnormal Value Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Postdose During the Study
QTcF Interval (msec): ≥30 change from baseline and >450
|
0 Participants
|
—
|
—
|
1 Participants
|
0 Participants
|
|
Part A: Number of Participants Who Meet the Markedly Abnormal Value Criteria for Safety Electrocardiogram (ECG) Parameters at Least Once Postdose During the Study
QRS Duration (msec): ≤80
|
5 Participants
|
—
|
—
|
4 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 8 (Day 56) in Parts B and CPopulation: Full Analysis Set included participants who received at least 1 dose of study drug, had baseline measure and at least 1 evaluable post-dose value. Overall number of participants analyzed is the number of participants available for analyses.
MWT: validated, objective measure that evaluates person's ability to remain awake under soporific conditions for defined period. During each MWT session (1 session=40 minutes), participants were instructed to sit quietly and remain awake for as long as possible. Sleep latency in each session was recorded on electroencephalography (EEG). If no sleep had been observed according to these rules, then latency= 40 minutes. Mixed-effect model for repeated measures (MMRM) was used for analysis. Due to early termination of the study, no post-baseline efficacy data for this outcome measure was collected and analyzed for participants in Part C: TAK-994 180 mg.
Outcome measures
| Measure |
Part B: FTAK-994 90 mg
n=11 Participants
TAK-994 90 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: TAK-994 180 mg
n=9 Participants
TAK-994 180 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part C: TAK-994 180 mg
TAK-994 180 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: Placebo
n=12 Participants
TAK-994 placebo-matching tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: TAK-994 30 mg
n=9 Participants
TAK-994 30 mg tablets, orally, BID for 56 days, in participants with NT1.
|
|---|---|---|---|---|---|
|
Parts B and C: Change From Baseline in Average Sleep Latency as Assessed by the Maintenance of Wakefulness Test (MWT)
|
27.4 minutes (min)
Standard Error 2.17
|
32.6 minutes (min)
Standard Error 2.25
|
—
|
-2.5 minutes (min)
Standard Error 2.19
|
23.9 minutes (min)
Standard Error 2.27
|
SECONDARY outcome
Timeframe: Pre-dose and at multiple time points (up to 14 hours) post-dose at Day 1 in Part APopulation: Pharmacokinetic (PK) Analysis Set included all participants who received at least 1 dose of TAK-994 and had at least 1 measurable plasma concentration. Overall number of participants analyzed is the number of participants available for analyses.
Outcome measures
| Measure |
Part B: FTAK-994 90 mg
TAK-994 90 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: TAK-994 180 mg
TAK-994 180 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part C: TAK-994 180 mg
TAK-994 180 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: Placebo
n=6 Participants
TAK-994 placebo-matching tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: TAK-994 30 mg
n=8 Participants
TAK-994 30 mg tablets, orally, BID for 56 days, in participants with NT1.
|
|---|---|---|---|---|---|
|
Part A: Cmax: Maximum Observed Plasma Concentration After Single Dose of TAK-994 at Day 1
Cmax (ng/mL); Following First (AM) Dose at Day 1
|
—
|
—
|
—
|
305.5 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 68.3
|
679.1 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 24.5
|
|
Part A: Cmax: Maximum Observed Plasma Concentration After Single Dose of TAK-994 at Day 1
Cmax (ng/mL); Following Second (PM) Dose at Day 1
|
—
|
—
|
—
|
437.1 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 46.9
|
1127 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 26.4
|
SECONDARY outcome
Timeframe: Pre-dose and at multiple time points (Up to 14 hours) post-dose at Day 1 in Part APopulation: PK Analysis Set included all participants who received at least 1 dose of TAK-994 and had at least 1 measurable plasma concentration. Overall number of participants analyzed is the number of participants available for analyses.
Outcome measures
| Measure |
Part B: FTAK-994 90 mg
TAK-994 90 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: TAK-994 180 mg
TAK-994 180 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part C: TAK-994 180 mg
TAK-994 180 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: Placebo
n=6 Participants
TAK-994 placebo-matching tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: TAK-994 30 mg
n=8 Participants
TAK-994 30 mg tablets, orally, BID for 56 days, in participants with NT1.
|
|---|---|---|---|---|---|
|
Part A: Tmax: Time of First Occurrence of Cmax After Single Dose of TAK-994 at Day 1
Tmax (h): Following First (AM) Dose at Day 1
|
—
|
—
|
—
|
1.19 hours (h)
Interval 1.0 to 5.03
|
1.00 hours (h)
Interval 1.0 to 5.0
|
|
Part A: Tmax: Time of First Occurrence of Cmax After Single Dose of TAK-994 at Day 1
Tmax (h): Following Second (PM) Dose at Day 1
|
—
|
—
|
—
|
2.04 hours (h)
Interval 1.02 to 4.0
|
1.75 hours (h)
Interval 1.42 to 2.08
|
SECONDARY outcome
Timeframe: Pre-dose and at multiple time points (up to 24 hours) post-dose at Day 1 in Part APopulation: PK Analysis Set included all participants who received at least 1 dose of TAK-994 and had at least 1 measurable plasma concentration. Overall number analyzed is the number of participants with data available for analyses.
Outcome measures
| Measure |
Part B: FTAK-994 90 mg
TAK-994 90 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: TAK-994 180 mg
TAK-994 180 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part C: TAK-994 180 mg
TAK-994 180 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: Placebo
n=6 Participants
TAK-994 placebo-matching tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: TAK-994 30 mg
n=8 Participants
TAK-994 30 mg tablets, orally, BID for 56 days, in participants with NT1.
|
|---|---|---|---|---|---|
|
Part A: AUC(0-last): Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration After Single Dose of TAK-994 at Day 1
|
—
|
—
|
—
|
3700 nanograms*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 63.0
|
8559 nanograms*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 26.7
|
SECONDARY outcome
Timeframe: Pre-dose and at multiple time points (up to 14 hours) post-dose at Day 28 in Part APopulation: PK Analysis Set included all participants who received at least 1 dose of TAK-994 and had at least 1 measurable plasma concentration.
Outcome measures
| Measure |
Part B: FTAK-994 90 mg
TAK-994 90 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: TAK-994 180 mg
TAK-994 180 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part C: TAK-994 180 mg
TAK-994 180 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: Placebo
n=7 Participants
TAK-994 placebo-matching tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: TAK-994 30 mg
n=8 Participants
TAK-994 30 mg tablets, orally, BID for 56 days, in participants with NT1.
|
|---|---|---|---|---|---|
|
Part A: Cmax: Maximum Observed Plasma Concentration After Multiple Doses of TAK-994 at Day 28
Cmax (ng/mL); Following First (AM) Dose at Day 28
|
—
|
—
|
—
|
377.5 ng/mL
Geometric Coefficient of Variation 36.6
|
856.9 ng/mL
Geometric Coefficient of Variation 31.6
|
|
Part A: Cmax: Maximum Observed Plasma Concentration After Multiple Doses of TAK-994 at Day 28
Cmax (ng/mL); Following Second (PM) Dose at Day 28
|
—
|
—
|
—
|
416.0 ng/mL
Geometric Coefficient of Variation 40.9
|
829.4 ng/mL
Geometric Coefficient of Variation 28.4
|
SECONDARY outcome
Timeframe: Pre-dose and at multiple time points (up to 14 hours) post-dose at Day 28 in Part APopulation: PK Analysis Set included all participants who received at least 1 dose of TAK-994 and had at least 1 measurable plasma concentration.
Outcome measures
| Measure |
Part B: FTAK-994 90 mg
TAK-994 90 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: TAK-994 180 mg
TAK-994 180 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part C: TAK-994 180 mg
TAK-994 180 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: Placebo
n=7 Participants
TAK-994 placebo-matching tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: TAK-994 30 mg
n=8 Participants
TAK-994 30 mg tablets, orally, BID for 56 days, in participants with NT1.
|
|---|---|---|---|---|---|
|
Part A: Tmax: Time of First Occurrence of Cmax After Multiple Doses of TAK-994 at Day 28
Tmax (h): Following First (AM) Dose at Day 28
|
—
|
—
|
—
|
1.03 hours (h)
Interval 0.93 to 3.1
|
1.00 hours (h)
Interval 0.9 to 1.0
|
|
Part A: Tmax: Time of First Occurrence of Cmax After Multiple Doses of TAK-994 at Day 28
Tmax (h): Following Second (PM) Dose at Day 28
|
—
|
—
|
—
|
2.15 hours (h)
Interval 2.0 to 4.05
|
3.46 hours (h)
Interval 1.5 to 7.0
|
SECONDARY outcome
Timeframe: Pre-dose and at multiple time points (Up to 12 hours) post-dose at Day 28 in Part APopulation: PK Analysis Set included all participants who received at least 1 dose of TAK-994 and had at least 1 measurable plasma concentration.
Outcome measures
| Measure |
Part B: FTAK-994 90 mg
TAK-994 90 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: TAK-994 180 mg
TAK-994 180 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part C: TAK-994 180 mg
TAK-994 180 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: Placebo
n=7 Participants
TAK-994 placebo-matching tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: TAK-994 30 mg
n=8 Participants
TAK-994 30 mg tablets, orally, BID for 56 days, in participants with NT1.
|
|---|---|---|---|---|---|
|
Part A: AUC(0-t): Area Under the Concentration-time Curve From Time 0 to Time Tau Over a Dosing Interval of TAK-994 at Day 28
|
—
|
—
|
—
|
2968 ng*h/mL
Geometric Coefficient of Variation 33.1
|
6438 ng*h/mL
Geometric Coefficient of Variation 22.6
|
SECONDARY outcome
Timeframe: Baseline and Week 8 (Day 56) in Parts B and CPopulation: Full Analysis Set included participants who received at least 1 dose of study drug, had baseline measure and at least 1 evaluable post-dose value. Overall number of participants analyzed is the number of participants available for analyses.
The ESS is a subjective, self-administered, validated scale (scored 0 to 3) to respond to each of the 8 questions of daily life that asks participants how likely they are to fall asleep in those situations. The scores are summed to give an overall score of 0 to 24. Higher scores indicate stronger subjective daytime sleepiness, and scores below 10 are considered to be within the normal range. MMRM was used for analysis. Due to early termination of the study, no post-baseline secondary efficacy data for this outcome measure was collected and analyzed for participants in Part C: TAK-994 180 mg.
Outcome measures
| Measure |
Part B: FTAK-994 90 mg
n=11 Participants
TAK-994 90 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: TAK-994 180 mg
n=9 Participants
TAK-994 180 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part C: TAK-994 180 mg
TAK-994 180 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: Placebo
n=12 Participants
TAK-994 placebo-matching tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: TAK-994 30 mg
n=10 Participants
TAK-994 30 mg tablets, orally, BID for 56 days, in participants with NT1.
|
|---|---|---|---|---|---|
|
Parts B and C: Change From Baseline in the Epworth Sleepiness Scale (ESS) Total Score to Week 8
|
-13.5 score on a scale
Standard Error 1.32
|
-15.1 score on a scale
Standard Error 1.41
|
—
|
-2.1 score on a scale
Standard Error 1.35
|
-12.2 score on a scale
Standard Error 1.41
|
SECONDARY outcome
Timeframe: Baseline and Week 8 (Day 56) in Parts B and CPopulation: Full Analysis Set included participants who received at least 1 dose of study drug, had baseline measure and at least 1 evaluable post-dose value. Overall number of participants analyzed is the number of participants available for analyses.
Participants will complete a daily patient-reported sleep diary to record self-reported narcolepsy symptoms. Participants will record episodes of cataplexy in the diary. The total number of events averaged for a week will be reported. WCR = (Total number of cataplexy over a number of non-missing diary days for a given duration/number of Non-missing diary days in that duration)\*7. MMRM was used for the analysis. Due to early termination of the study, no secondary efficacy data was collected and analyzed for participants in Part C: TAK-994 180 mg.
Outcome measures
| Measure |
Part B: FTAK-994 90 mg
n=11 Participants
TAK-994 90 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: TAK-994 180 mg
n=8 Participants
TAK-994 180 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part C: TAK-994 180 mg
TAK-994 180 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: Placebo
n=10 Participants
TAK-994 placebo-matching tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: TAK-994 30 mg
n=10 Participants
TAK-994 30 mg tablets, orally, BID for 56 days, in participants with NT1.
|
|---|---|---|---|---|---|
|
Parts B and C: Change From Baseline in Weekly Cataplexy Rate (WCR) at Week 8
|
-11.91 cataplexy attacks per week
Standard Deviation 10.174
|
-15.74 cataplexy attacks per week
Standard Deviation 9.978
|
—
|
-6.58 cataplexy attacks per week
Standard Deviation 7.433
|
-16.17 cataplexy attacks per week
Standard Deviation 20.979
|
SECONDARY outcome
Timeframe: First dose of study drug to end of study follow-up (up to Day 63) in Parts B and CPopulation: Safety Analysis Set included all participants who were randomized and received at least 1 dose of the study drug.
An 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 is defined as an AE with an onset that occurs after receiving study drug.
Outcome measures
| Measure |
Part B: FTAK-994 90 mg
n=20 Participants
TAK-994 90 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: TAK-994 180 mg
n=19 Participants
TAK-994 180 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part C: TAK-994 180 mg
n=2 Participants
TAK-994 180 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: Placebo
n=17 Participants
TAK-994 placebo-matching tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: TAK-994 30 mg
n=17 Participants
TAK-994 30 mg tablets, orally, BID for 56 days, in participants with NT1.
|
|---|---|---|---|---|---|
|
Parts B and C: Number of Participants Who Experience at Least 1 TEAE During the Study
|
17 Participants
|
14 Participants
|
2 Participants
|
4 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Up to Day 63 in Parts B and CPopulation: Safety Analysis Set included all participants who were randomized and received at least 1 dose of the study drug.
Standard safety laboratory values (serum chemistry, hematology, and urine analysis) were collected and compared to pre-specified criteria for Markedly Abnormal Values throughout the study. Markedly abnormal values criteria: Alanine Aminotransferase (U/L):\>3xULN, Aspartate Aminotransferase(U/L):\>3xULN; Bilirubin micromoles/litre (umol/L):\>1.5xULN; Calcium(mmol/L):\<1.92, \>2.77; Potassium(mmol/L):\<3.0, \>5.3. Only categories with at least one participant with event are reported.
Outcome measures
| Measure |
Part B: FTAK-994 90 mg
n=20 Participants
TAK-994 90 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: TAK-994 180 mg
n=19 Participants
TAK-994 180 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part C: TAK-994 180 mg
n=2 Participants
TAK-994 180 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: Placebo
n=17 Participants
TAK-994 placebo-matching tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: TAK-994 30 mg
n=17 Participants
TAK-994 30 mg tablets, orally, BID for 56 days, in participants with NT1.
|
|---|---|---|---|---|---|
|
Parts B and C: Number of Participants Who Met the Markedly Abnormal Value Criteria for Safety Laboratory Tests at Least Once Postdose During the Study
Alanine Aminotransferase (ALT) [U/L)]: >3 × Upper limit normal (ULN)
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Parts B and C: Number of Participants Who Met the Markedly Abnormal Value Criteria for Safety Laboratory Tests at Least Once Postdose During the Study
Aspartate Aminotransferase (AST) [(U/L)]: >3 × ULN
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Parts B and C: Number of Participants Who Met the Markedly Abnormal Value Criteria for Safety Laboratory Tests at Least Once Postdose During the Study
Bilirubin (µmol/L): >1.5 × ULN
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Parts B and C: Number of Participants Who Met the Markedly Abnormal Value Criteria for Safety Laboratory Tests at Least Once Postdose During the Study
Calcium (mmol/L): <1.92
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Parts B and C: Number of Participants Who Met the Markedly Abnormal Value Criteria for Safety Laboratory Tests at Least Once Postdose During the Study
Potassium (mmol/L): <3.0
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Parts B and C: Number of Participants Who Met the Markedly Abnormal Value Criteria for Safety Laboratory Tests at Least Once Postdose During the Study
Potassium (mmol/L): >5.3
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to Day 63 in Parts B and CPopulation: Safety Analysis Set included all participants who were randomized and received at least 1 dose of the study drug.
Vital signs (body temperature and sitting blood pressure) were collected and compared to pre-specified criteria for markedly abnormal values throughout the study. Markedly abnormal values criteria: Systolic Blood Pressure millimeters of mercury (mmHg): \<90, ≥160, Change from Pre-Dose \>20, Change from Pre-Dose \>30, Time-matched Change from Baseline \> 20, Time-matched Change from Baseline \> 30; Diastolic Blood Pressure (mmHg): \<50, ≥100, Change from Pre-Dose \>20, Change from Pre-Dose \>30, Time-matched Change from Baseline \> 20, Time-matched Change from Baseline \> 30; Respiratory Rate (breaths/min): \>21.Only categories with at least one participant with event are reported.
Outcome measures
| Measure |
Part B: FTAK-994 90 mg
n=20 Participants
TAK-994 90 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: TAK-994 180 mg
n=19 Participants
TAK-994 180 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part C: TAK-994 180 mg
n=2 Participants
TAK-994 180 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: Placebo
n=17 Participants
TAK-994 placebo-matching tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: TAK-994 30 mg
n=17 Participants
TAK-994 30 mg tablets, orally, BID for 56 days, in participants with NT1.
|
|---|---|---|---|---|---|
|
Parts B and C: Number of Participants Who Met the Markedly Abnormal Value Criteria for Vital Sign Measurements at Least Once Postdose During the Study
Systolic blood pressure (mmHg): <90
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
|
Parts B and C: Number of Participants Who Met the Markedly Abnormal Value Criteria for Vital Sign Measurements at Least Once Postdose During the Study
Systolic blood pressure (mmHg):>=160
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Parts B and C: Number of Participants Who Met the Markedly Abnormal Value Criteria for Vital Sign Measurements at Least Once Postdose During the Study
Systolic blood pressure (mmHg): Change from Predose >20
|
10 Participants
|
10 Participants
|
0 Participants
|
5 Participants
|
7 Participants
|
|
Parts B and C: Number of Participants Who Met the Markedly Abnormal Value Criteria for Vital Sign Measurements at Least Once Postdose During the Study
Systolic blood pressure (mmHg): Change from Predose >30
|
6 Participants
|
5 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Parts B and C: Number of Participants Who Met the Markedly Abnormal Value Criteria for Vital Sign Measurements at Least Once Postdose During the Study
Systolic blood pressure (mmHg): Time-matched Change from Baseline >20
|
13 Participants
|
14 Participants
|
1 Participants
|
2 Participants
|
11 Participants
|
|
Parts B and C: Number of Participants Who Met the Markedly Abnormal Value Criteria for Vital Sign Measurements at Least Once Postdose During the Study
Systolic blood pressure (mmHg): Time-matched Change from Baseline >30
|
3 Participants
|
5 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
|
Parts B and C: Number of Participants Who Met the Markedly Abnormal Value Criteria for Vital Sign Measurements at Least Once Postdose During the Study
Diastolic blood pressure (mmHg): <50
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Parts B and C: Number of Participants Who Met the Markedly Abnormal Value Criteria for Vital Sign Measurements at Least Once Postdose During the Study
Diastolic blood pressure (mmHg): >=100
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Parts B and C: Number of Participants Who Met the Markedly Abnormal Value Criteria for Vital Sign Measurements at Least Once Postdose During the Study
Diastolic blood pressure (mmHg): Change from Predose >20
|
5 Participants
|
9 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Parts B and C: Number of Participants Who Met the Markedly Abnormal Value Criteria for Vital Sign Measurements at Least Once Postdose During the Study
Diastolic blood pressure (mmHg): Change from Predose >30
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Parts B and C: Number of Participants Who Met the Markedly Abnormal Value Criteria for Vital Sign Measurements at Least Once Postdose During the Study
Diastolic blood pressure (mmHg): Time-matched Change from Baseline >20
|
7 Participants
|
7 Participants
|
0 Participants
|
2 Participants
|
5 Participants
|
|
Parts B and C: Number of Participants Who Met the Markedly Abnormal Value Criteria for Vital Sign Measurements at Least Once Postdose During the Study
Diastolic blood pressure (mmHg): Time-matched Change from Baseline >30
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Parts B and C: Number of Participants Who Met the Markedly Abnormal Value Criteria for Vital Sign Measurements at Least Once Postdose During the Study
Respiratory Rate [Breaths per minute (breaths/min)]: >21
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to Day 63 in Parts B and CPopulation: Safety Analysis Set included all participants who were randomized and received at least 1 dose of the study drug.
A 12 lead ECG was performed, the ECG values were compared to pre-specified criteria for markedly abnormal values. Markedly abnormal values criteria: PR Interval (msec): ≤80, ≥200; QRS Duration (msec): ≤80, ≥180. Only categories with at least one participant with event are reported.
Outcome measures
| Measure |
Part B: FTAK-994 90 mg
n=20 Participants
TAK-994 90 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: TAK-994 180 mg
n=19 Participants
TAK-994 180 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part C: TAK-994 180 mg
n=2 Participants
TAK-994 180 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: Placebo
n=17 Participants
TAK-994 placebo-matching tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: TAK-994 30 mg
n=17 Participants
TAK-994 30 mg tablets, orally, BID for 56 days, in participants with NT1.
|
|---|---|---|---|---|---|
|
Parts B and C: Number of Participants Who Met the Markedly Abnormal Value Criteria for ECG Parameters at Least Once Postdose During the Study
PR Interval (msec): >=200
|
1 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Parts B and C: Number of Participants Who Met the Markedly Abnormal Value Criteria for ECG Parameters at Least Once Postdose During the Study
QRS Duration (msec):<=80
|
7 Participants
|
4 Participants
|
0 Participants
|
4 Participants
|
3 Participants
|
Adverse Events
Part A: Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part A: TAK-994 120 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part A: TAK-994 180 mg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Part B: Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Part B: TAK-994 30 mg
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Part B: TAK-994 90 mg
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Part B: TAK-994 180 mg
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Part C: TAK-994 180 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A: Placebo
n=7 participants at risk
TAK-994 placebo-matching tablets, orally, BID for 28 days, in participants with NT1.
|
Part A: TAK-994 120 mg
n=7 participants at risk
TAK-994 120 mg, orally, BID for 28 days, in participants with NT1.
|
Part A: TAK-994 180 mg
n=8 participants at risk
TAK-994 180 mg, orally, BID for 28 days, in participants with NT1.
|
Part B: Placebo
n=17 participants at risk
TAK-994 placebo-matching tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: TAK-994 30 mg
n=17 participants at risk
TAK-994 30 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: TAK-994 90 mg
n=20 participants at risk
TAK-994 90 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: TAK-994 180 mg
n=19 participants at risk
TAK-994 180 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part C: TAK-994 180 mg
n=2 participants at risk
TAK-994 180 mg tablets, orally, BID for 56 days, in participants with NT1
|
|---|---|---|---|---|---|---|---|---|
|
Hepatobiliary disorders
Hepatitis acute
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and 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 A: Placebo
n=7 participants at risk
TAK-994 placebo-matching tablets, orally, BID for 28 days, in participants with NT1.
|
Part A: TAK-994 120 mg
n=7 participants at risk
TAK-994 120 mg, orally, BID for 28 days, in participants with NT1.
|
Part A: TAK-994 180 mg
n=8 participants at risk
TAK-994 180 mg, orally, BID for 28 days, in participants with NT1.
|
Part B: Placebo
n=17 participants at risk
TAK-994 placebo-matching tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: TAK-994 30 mg
n=17 participants at risk
TAK-994 30 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: TAK-994 90 mg
n=20 participants at risk
TAK-994 90 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part B: TAK-994 180 mg
n=19 participants at risk
TAK-994 180 mg tablets, orally, BID for 56 days, in participants with NT1.
|
Part C: TAK-994 180 mg
n=2 participants at risk
TAK-994 180 mg tablets, orally, BID for 56 days, in participants with NT1
|
|---|---|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
1/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and 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
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
1/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
15.0%
3/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and 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 mass
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
1/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and 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
Acute sinusitis
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
1/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and 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
Agitation
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
1/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
20.0%
4/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and 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
Anxiety
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.5%
2/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
2/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and 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
Blepharospasm
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
1/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood pressure increased
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
2/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood urea increased
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and 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
Constipation
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.5%
2/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
1/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
1/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and 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
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and 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
Dyspepsia
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
1/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
1/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Social circumstances
Ex-tobacco user
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and 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 hard
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and 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
Fatigue
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and 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 jittery
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
1/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and 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
Giardiasis
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
1/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Glutamate dehydrogenase increased
|
14.3%
1/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Granulocytopenia
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and 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
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
23.5%
4/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Heart rate increased
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
14.3%
1/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and 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
Hyperhidrosis
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.5%
2/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
100.0%
2/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and 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
Hypertension
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and 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
Hypervigilance
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and 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
Initial insomnia
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and 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
Insomnia
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
1/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.0%
2/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
15.8%
3/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
100.0%
2/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
1/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
29.4%
5/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
10/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
42.1%
8/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and 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
Middle insomnia
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and 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
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and 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
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
42.9%
3/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
62.5%
5/8 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
1/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
29.4%
5/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
10/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
31.6%
6/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
100.0%
2/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
1/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and 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
Puncture site erythema
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and 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
Pyrexia
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
1/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and 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 papular
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and 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
Rotator cuff syndrome
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and 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
Salivary hypersecretion
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
37.5%
3/8 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
15.0%
3/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
10.5%
2/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
1/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and 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
Skin laceration
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
1/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
1/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and 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
Sleep disorder
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and 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
Sneezing
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and 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
Suicidal ideation
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and 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
Tachycardia
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and 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
Tension headache
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and 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
Tremor
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
50.0%
1/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and 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
Urinary tract infection
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and 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
Vaccination complication
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and 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
Vision blurred
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Reproductive system and breast disorders
Vulvovaginal inflammation
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
1/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Weight increased
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.3%
1/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pleomorphic adenoma
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and 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%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood pressure diastolic increased
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood pressure systolic increased
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and 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
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.9%
1/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and 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
Vomiting
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and 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
Bacterial disease carrier
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and 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
Gastroenteritis viral
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/17 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
5.0%
1/20 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/19 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/2 • First dose of study treatment to end of study follow-up (up to Day 35 in Part A and up to Day 63 in Parts B and C)
At each visit the investigator had to document any occurrence of adverse events and 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