Trial Outcomes & Findings for A Study of LY3478045 in Healthy Participants (NCT NCT04270370)
NCT ID: NCT04270370
Last Updated: 2024-07-25
Results Overview
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, is reported in the Reported Adverse Events module.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
72 participants
Primary outcome timeframe
Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
Results posted on
2024-07-25
Participant Flow
The study included two parts (Part A and Part B). A single ascending oral dose of LY3478045 was administered in Part A, and multiple ascending oral doses of LY3478045 were administered once daily (QD) in Part B. Participants in a few reporting arms of Part B received a 40-milligram (mg) oral dose of atorvastatin 4 hours after breakfast on Day -2 and 4 hours after LY3478045 administration on Day 7.
Participant milestones
| Measure |
Placebo (Part A)
Participants received single oral dose of placebo on Day 1.
|
20 mg LY3478045 (Part A)
Participants received single oral dose of 20 mg LY3478045 on Day 1.
|
60 mg LY3478045 (Part A)
Participants received single oral dose of 60 mg LY3478045 on Day 1.
|
180 mg LY3478045 (Part A)
Participants received single oral dose of 180 mg LY3478045 on Day 1.
|
500 mg LY3478045 (Part A)
Participants received single oral dose of 500 mg LY3478045 on Day 1.
|
700 mg LY3478045 (Part A)
Participants received single oral dose of 700 mg LY3478045 on Day 1.
|
Placebo Once-daily (QD) (Part B)
Participants received oral dose of Placebo QD for 14 days.
|
Placebo QD + 40 mg Atorvastatin (Part B)
Participants received oral dose of placebo QD for 14 days and 40 mg atorvastatin administered orally 4 hours after breakfast on Day -2 and 4 hours after LY3478045 administration on Day 7.
|
60 mg LY3478045 QD (Part B)
Participants received oral dose of 60 mg LY3478045 QD for 14 days.
|
160 mg LY3478045 QD + 40 mg Atorvastatin (Part B)
Participants received oral dose of 160 mg LY3478045 QD for 14 days and 40 mg atorvastatin administered orally 4 hours after breakfast on Day -2 and 4 hours after LY3478045 administration on Day 7.
|
300 mg LY3478045 QD (Part B)
Participants received oral dose of 300 mg LY3478045 QD for 14 days.
|
360 mg LY3478045 QD + 40 mg Atorvastatin (Part B)
Participants received oral dose of 360 mg LY3478045 for 14 days and 40 mg atorvastatin administered orally 4 hours after breakfast on Day -2 and 4 hours after LY3478045 administration on Day 7.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
6
|
6
|
6
|
6
|
6
|
4
|
4
|
6
|
6
|
6
|
6
|
|
Overall Study
Received at Least One Dose of Study Drug
|
10
|
6
|
6
|
6
|
6
|
6
|
4
|
4
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
9
|
6
|
6
|
6
|
6
|
6
|
4
|
4
|
5
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo (Part A)
Participants received single oral dose of placebo on Day 1.
|
20 mg LY3478045 (Part A)
Participants received single oral dose of 20 mg LY3478045 on Day 1.
|
60 mg LY3478045 (Part A)
Participants received single oral dose of 60 mg LY3478045 on Day 1.
|
180 mg LY3478045 (Part A)
Participants received single oral dose of 180 mg LY3478045 on Day 1.
|
500 mg LY3478045 (Part A)
Participants received single oral dose of 500 mg LY3478045 on Day 1.
|
700 mg LY3478045 (Part A)
Participants received single oral dose of 700 mg LY3478045 on Day 1.
|
Placebo Once-daily (QD) (Part B)
Participants received oral dose of Placebo QD for 14 days.
|
Placebo QD + 40 mg Atorvastatin (Part B)
Participants received oral dose of placebo QD for 14 days and 40 mg atorvastatin administered orally 4 hours after breakfast on Day -2 and 4 hours after LY3478045 administration on Day 7.
|
60 mg LY3478045 QD (Part B)
Participants received oral dose of 60 mg LY3478045 QD for 14 days.
|
160 mg LY3478045 QD + 40 mg Atorvastatin (Part B)
Participants received oral dose of 160 mg LY3478045 QD for 14 days and 40 mg atorvastatin administered orally 4 hours after breakfast on Day -2 and 4 hours after LY3478045 administration on Day 7.
|
300 mg LY3478045 QD (Part B)
Participants received oral dose of 300 mg LY3478045 QD for 14 days.
|
360 mg LY3478045 QD + 40 mg Atorvastatin (Part B)
Participants received oral dose of 360 mg LY3478045 for 14 days and 40 mg atorvastatin administered orally 4 hours after breakfast on Day -2 and 4 hours after LY3478045 administration on Day 7.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Study of LY3478045 in Healthy Participants
Baseline characteristics by cohort
| Measure |
Placebo (Part A)
n=10 Participants
Participants received single oral dose of placebo on Day 1.
|
20 mg LY3478045 (Part A)
n=6 Participants
Participants received single oral dose of 20 mg LY3478045 on Day 1.
|
60 mg LY3478045 (Part A)
n=6 Participants
Participants received single oral dose of 60 mg LY3478045 on Day 1.
|
180 mg LY3478045 (Part A)
n=6 Participants
Participants received single oral dose of 180 mg LY3478045 on Day 1.
|
500 mg LY3478045 (Part A)
n=6 Participants
Participants received single oral dose of 500 mg LY3478045 on Day 1.
|
700 mg LY3478045 (Part A)
n=6 Participants
Participants received single oral dose of 700 mg LY3478045 on Day 1.
|
Placebo QD (Part B)
n=4 Participants
Participants received oral dose of placebo QD for 14 days.
|
Placebo QD + 40 mg Atorvastatin (Part B)
n=4 Participants
Participants received oral dose of placebo QD for 14 days and 40 mg atorvastatin administered orally 4 hours after breakfast on Day -2 and 4 hours after LY3478045 administration on Day 7.
|
60 mg LY3478045 QD (Part B)
n=6 Participants
Participants received oral dose of 60 mg LY3478045 QD for 14 days.
|
160 mg LY3478045 QD + 40 mg Atorvastatin (Part B)
n=6 Participants
Participants received oral dose of 160 mg LY3478045 QD for 14 days and 40 mg atorvastatin administered orally 4 hours after breakfast on Day -2 and 4 hours after LY3478045 administration on Day 7.
|
300 mg LY3478045 QD (Part B)
n=6 Participants
Participants received oral dose of 300 mg LY3478045 QD for 14 days.
|
360 mg LY3478045 QD + 40 mg Atorvastatin (Part B)
n=6 Participants
Participants received oral dose of 360 mg LY3478045 for 14 days and 40 mg atorvastatin administered orally 4 hours after breakfast on Day -2 and 4 hours after LY3478045 administration on Day 7.
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
43.9 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
43.0 years
STANDARD_DEVIATION 12.0 • n=7 Participants
|
40.2 years
STANDARD_DEVIATION 13.7 • n=5 Participants
|
42.3 years
STANDARD_DEVIATION 9.1 • n=4 Participants
|
47.8 years
STANDARD_DEVIATION 7.6 • n=21 Participants
|
50.5 years
STANDARD_DEVIATION 9.6 • n=8 Participants
|
52.0 years
STANDARD_DEVIATION 4.7 • n=8 Participants
|
48.3 years
STANDARD_DEVIATION 7.5 • n=24 Participants
|
35.8 years
STANDARD_DEVIATION 12.8 • n=42 Participants
|
36.5 years
STANDARD_DEVIATION 9.9 • n=42 Participants
|
48.0 years
STANDARD_DEVIATION 9.6 • n=42 Participants
|
54.8 years
STANDARD_DEVIATION 6.4 • n=42 Participants
|
44.9 years
STANDARD_DEVIATION 10.7 • n=36 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
35 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
37 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
27 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
45 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
4 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
29 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
42 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
72 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)Population: All enrolled participants who received at least one dose of study drug.
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, is reported in the Reported Adverse Events module.
Outcome measures
| Measure |
Placebo (Part A)
n=10 Participants
Participants received single oral dose of placebo on Day 1.
|
20 mg LY3478045 (Part A)
n=6 Participants
Participants received single oral dose of 20 mg LY3478045 on Day 1.
|
60 mg LY3478045 (Part A)
n=6 Participants
Participants received single oral dose of 60 mg LY3478045 on Day 1.
|
180 mg LY3478045 (Part A)
n=6 Participants
Participants received single oral dose of 180 mg LY3478045 on Day 1.
|
500 mg LY3478045 (Part A)
n=6 Participants
Participants received single oral dose of 500 mg LY3478045 on Day 1.
|
700 mg LY3478045 (Part A)
n=6 Participants
Participants received single oral dose of 700 mg LY3478045 on Day 1.
|
Placebo QD (Part B)
n=4 Participants
Participants received oral dose of placebo QD for 14 days.
|
Placebo QD + 40 mg Atorvastatin (Part B)
n=4 Participants
Participants received oral dose of placebo QD for 14 days and 40 mg atorvastatin administered orally 4 hours after breakfast on Day -2 and 4 hours after LY3478045 administration on Day 7.
|
60 mg LY3478045 QD (Part B)
n=6 Participants
Participants received oral dose of 60 mg LY3478045 QD for 14 days.
|
160 mg LY3478045 QD + 40 mg Atorvastatin (Part B)
n=6 Participants
Participants received oral dose of 160 mg LY3478045 QD for 14 days and 40 mg atorvastatin administered orally 4 hours after breakfast on Day -2 and 4 hours after LY3478045 administration on Day 7.
|
300 mg LY3478045 QD (Part B)
n=6 Participants
Participants received oral dose of 300 mg LY3478045 QD for 14 days.
|
360 mg LY3478045 QD + 40 mg Atorvastatin (Part B)
n=6 Participants
Participants received oral dose of 360 mg LY3478045 for 14 days and 40 mg atorvastatin administered orally 4 hours after breakfast on Day -2 and 4 hours after LY3478045 administration on Day 7.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Part A: Predose, 0.75, 1.5, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72 and 95 hours post dose; Part B: Day 1: Predose, 0.75, 1.5, 3, 4, 6, 8, 12, 16 and 24 hours post dose; Day 14: Predose ,0.75, 1.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post dosePopulation: All participants who received at least one dose of study drug and had evaluable PK data.
PK: AUC(0-inf) of LY3478045 was reported.
Outcome measures
| Measure |
Placebo (Part A)
n=6 Participants
Participants received single oral dose of placebo on Day 1.
|
20 mg LY3478045 (Part A)
n=6 Participants
Participants received single oral dose of 20 mg LY3478045 on Day 1.
|
60 mg LY3478045 (Part A)
n=6 Participants
Participants received single oral dose of 60 mg LY3478045 on Day 1.
|
180 mg LY3478045 (Part A)
n=6 Participants
Participants received single oral dose of 180 mg LY3478045 on Day 1.
|
500 mg LY3478045 (Part A)
n=6 Participants
Participants received single oral dose of 500 mg LY3478045 on Day 1.
|
700 mg LY3478045 (Part A)
n=6 Participants
Participants received single oral dose of 700 mg LY3478045 on Day 1.
|
Placebo QD (Part B)
n=6 Participants
Participants received oral dose of placebo QD for 14 days.
|
Placebo QD + 40 mg Atorvastatin (Part B)
n=6 Participants
Participants received oral dose of placebo QD for 14 days and 40 mg atorvastatin administered orally 4 hours after breakfast on Day -2 and 4 hours after LY3478045 administration on Day 7.
|
60 mg LY3478045 QD (Part B)
n=6 Participants
Participants received oral dose of 60 mg LY3478045 QD for 14 days.
|
160 mg LY3478045 QD + 40 mg Atorvastatin (Part B)
Participants received oral dose of 160 mg LY3478045 QD for 14 days and 40 mg atorvastatin administered orally 4 hours after breakfast on Day -2 and 4 hours after LY3478045 administration on Day 7.
|
300 mg LY3478045 QD (Part B)
Participants received oral dose of 300 mg LY3478045 QD for 14 days.
|
360 mg LY3478045 QD + 40 mg Atorvastatin (Part B)
Participants received oral dose of 360 mg LY3478045 for 14 days and 40 mg atorvastatin administered orally 4 hours after breakfast on Day -2 and 4 hours after LY3478045 administration on Day 7.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of LY3478045
|
7410 nanogram*hour per milliliter (ng*h/ mL)
Geometric Coefficient of Variation 38
|
24300 nanogram*hour per milliliter (ng*h/ mL)
Geometric Coefficient of Variation 51
|
59900 nanogram*hour per milliliter (ng*h/ mL)
Geometric Coefficient of Variation 32
|
275000 nanogram*hour per milliliter (ng*h/ mL)
Geometric Coefficient of Variation 39
|
382000 nanogram*hour per milliliter (ng*h/ mL)
Geometric Coefficient of Variation 19
|
67800 nanogram*hour per milliliter (ng*h/ mL)
Geometric Coefficient of Variation 154
|
98900 nanogram*hour per milliliter (ng*h/ mL)
Geometric Coefficient of Variation 37
|
388000 nanogram*hour per milliliter (ng*h/ mL)
Geometric Coefficient of Variation 71
|
484000 nanogram*hour per milliliter (ng*h/ mL)
Geometric Coefficient of Variation 48
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part A: Predose, 0.75, 1.5, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72 and 95 hours post dose; Part B: Day 1: Predose, 0.75, 1.5, 3, 4, 6, 8, 12, 16 and 24 hours post dose; Day 14: Predose ,0.75, 1.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post dosePopulation: All participants who received at least one dose of study drug and had evaluable PK data.
PK: Cmax of LY3478045 was reported.
Outcome measures
| Measure |
Placebo (Part A)
n=6 Participants
Participants received single oral dose of placebo on Day 1.
|
20 mg LY3478045 (Part A)
n=6 Participants
Participants received single oral dose of 20 mg LY3478045 on Day 1.
|
60 mg LY3478045 (Part A)
n=6 Participants
Participants received single oral dose of 60 mg LY3478045 on Day 1.
|
180 mg LY3478045 (Part A)
n=6 Participants
Participants received single oral dose of 180 mg LY3478045 on Day 1.
|
500 mg LY3478045 (Part A)
n=6 Participants
Participants received single oral dose of 500 mg LY3478045 on Day 1.
|
700 mg LY3478045 (Part A)
n=6 Participants
Participants received single oral dose of 700 mg LY3478045 on Day 1.
|
Placebo QD (Part B)
n=6 Participants
Participants received oral dose of placebo QD for 14 days.
|
Placebo QD + 40 mg Atorvastatin (Part B)
n=6 Participants
Participants received oral dose of placebo QD for 14 days and 40 mg atorvastatin administered orally 4 hours after breakfast on Day -2 and 4 hours after LY3478045 administration on Day 7.
|
60 mg LY3478045 QD (Part B)
n=6 Participants
Participants received oral dose of 60 mg LY3478045 QD for 14 days.
|
160 mg LY3478045 QD + 40 mg Atorvastatin (Part B)
Participants received oral dose of 160 mg LY3478045 QD for 14 days and 40 mg atorvastatin administered orally 4 hours after breakfast on Day -2 and 4 hours after LY3478045 administration on Day 7.
|
300 mg LY3478045 QD (Part B)
Participants received oral dose of 300 mg LY3478045 QD for 14 days.
|
360 mg LY3478045 QD + 40 mg Atorvastatin (Part B)
Participants received oral dose of 360 mg LY3478045 for 14 days and 40 mg atorvastatin administered orally 4 hours after breakfast on Day -2 and 4 hours after LY3478045 administration on Day 7.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK: Maximum Concentration (Cmax) of LY3478045
|
303 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 25
|
1280 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 34
|
3670 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 24
|
14500 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 28
|
18500 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 34
|
2360 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 40
|
5920 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 33
|
19500 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 19
|
22400 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 27
|
—
|
—
|
—
|
Adverse Events
Placebo (Part A)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
20 mg LY3478045 (Part A)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
60 mg LY3478045 (Part A)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
180 mg LY3478045 (Part A)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
500 mg LY3478045 (Part A)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
700 mg LY3478045 (Part A)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo QD (Part B)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo QD + 40 mg Atorvastatin (Part B)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
60 mg LY3478045 QD (Part B)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
160 mg LY3478045 QD + 40 mg Atorvastatin (Part B)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
300 mg LY3478045 QD (Part B)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
360 mg LY3478045 QD + 40 mg Atorvastatin (Part B)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo (Part A)
n=10 participants at risk
Participants received single oral dose of placebo on Day 1.
|
20 mg LY3478045 (Part A)
n=6 participants at risk
Participants received single oral dose of 20 mg LY3478045 on Day 1.
|
60 mg LY3478045 (Part A)
n=6 participants at risk
Participants received single oral dose of 60 mg LY3478045 on Day 1.
|
180 mg LY3478045 (Part A)
n=6 participants at risk
Participants received single oral dose of 180 mg LY3478045 on Day 1.
|
500 mg LY3478045 (Part A)
n=6 participants at risk
Participants received single oral dose of 500 mg LY3478045 on Day 1.
|
700 mg LY3478045 (Part A)
n=6 participants at risk
Participants received single oral dose of 700 mg LY3478045 on Day 1.
|
Placebo QD (Part B)
n=4 participants at risk
Participants received oral dose of placebo QD for 14 days.
|
Placebo QD + 40 mg Atorvastatin (Part B)
n=4 participants at risk
Participants received oral dose of placebo QD for 14 days and 40 mg atorvastatin administered orally 4 hours after breakfast on Day -2 and 4 hours after LY3478045 administration on Day 7.
|
60 mg LY3478045 QD (Part B)
n=6 participants at risk
Participants received oral dose of 60 mg LY3478045 QD for 14 days.
|
160 mg LY3478045 QD + 40 mg Atorvastatin (Part B)
n=6 participants at risk
Participants received oral dose of 160 mg LY3478045 QD for 14 days and 40 mg atorvastatin administered orally 4 hours after breakfast on Day -2 and 4 hours after LY3478045 administration on Day 7.
|
300 mg LY3478045 QD (Part B)
n=6 participants at risk
Participants received oral dose of 300 mg LY3478045 QD for 14 days.
|
360 mg LY3478045 QD + 40 mg Atorvastatin (Part B)
n=6 participants at risk
Participants received oral dose of 360 mg LY3478045 for 14 days and 40 mg atorvastatin administered orally 4 hours after breakfast on Day -2 and 4 hours after LY3478045 administration on Day 7.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Seizure
|
0.00%
0/10 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Placebo (Part A)
n=10 participants at risk
Participants received single oral dose of placebo on Day 1.
|
20 mg LY3478045 (Part A)
n=6 participants at risk
Participants received single oral dose of 20 mg LY3478045 on Day 1.
|
60 mg LY3478045 (Part A)
n=6 participants at risk
Participants received single oral dose of 60 mg LY3478045 on Day 1.
|
180 mg LY3478045 (Part A)
n=6 participants at risk
Participants received single oral dose of 180 mg LY3478045 on Day 1.
|
500 mg LY3478045 (Part A)
n=6 participants at risk
Participants received single oral dose of 500 mg LY3478045 on Day 1.
|
700 mg LY3478045 (Part A)
n=6 participants at risk
Participants received single oral dose of 700 mg LY3478045 on Day 1.
|
Placebo QD (Part B)
n=4 participants at risk
Participants received oral dose of placebo QD for 14 days.
|
Placebo QD + 40 mg Atorvastatin (Part B)
n=4 participants at risk
Participants received oral dose of placebo QD for 14 days and 40 mg atorvastatin administered orally 4 hours after breakfast on Day -2 and 4 hours after LY3478045 administration on Day 7.
|
60 mg LY3478045 QD (Part B)
n=6 participants at risk
Participants received oral dose of 60 mg LY3478045 QD for 14 days.
|
160 mg LY3478045 QD + 40 mg Atorvastatin (Part B)
n=6 participants at risk
Participants received oral dose of 160 mg LY3478045 QD for 14 days and 40 mg atorvastatin administered orally 4 hours after breakfast on Day -2 and 4 hours after LY3478045 administration on Day 7.
|
300 mg LY3478045 QD (Part B)
n=6 participants at risk
Participants received oral dose of 300 mg LY3478045 QD for 14 days.
|
360 mg LY3478045 QD + 40 mg Atorvastatin (Part B)
n=6 participants at risk
Participants received oral dose of 360 mg LY3478045 for 14 days and 40 mg atorvastatin administered orally 4 hours after breakfast on Day -2 and 4 hours after LY3478045 administration on Day 7.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Corona virus infection
|
10.0%
1/10 • Number of events 1 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/10 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/10 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/10 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
|
Eye disorders
Vision blurred
|
10.0%
1/10 • Number of events 1 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/10 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/10 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
0.00%
0/10 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
|
General disorders
Medical device site irritation
|
0.00%
0/10 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/10 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
|
General disorders
Pain
|
0.00%
0/10 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/10 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
10.0%
1/10 • Number of events 1 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
10.0%
1/10 • Number of events 1 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/10 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 1 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
|
Vascular disorders
Flushing
|
0.00%
0/10 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/4 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
25.0%
1/4 • Number of events 4 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline Up to Final Follow-up: Up to 14 Days (Part A) and up to 28 Days (Part B)
All enrolled participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60