Trial Outcomes & Findings for A Study of LY3337641 in Japanese and Caucasian Healthy Participants (NCT NCT03083561)
NCT ID: NCT03083561
Last Updated: 2023-08-25
Results Overview
Clinically significant events were defined as serious adverse events (SAE). A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
36 participants
Primary outcome timeframe
Up To 31 Days
Results posted on
2023-08-25
Participant Flow
The study consisted of multiple-doses (MD) in Cohort 1 and single-dose (SD) for Cohorts 2, 3, and 4.
Participant milestones
| Measure |
Placebo SD
Participants received single oral dose of placebo tablet with a two week follow-up period.
|
5 mg LY3337641 SD
Participants received single oral dose of 5 mg LY3337641 tablet with a two week follow-up period.
|
80 mg LY3337641 SD
Participants received single oral dose of 80 mg LY3337641 tablet with a two week follow-up period.
|
160 mg LY3337641 SD
Participants received single oral dose of 160 mg LY3337641 tablet with a two week follow-up period.
|
Placebo MD
Participants received multiple oral doses of placebo tablet once daily for two weeks with a two week follow-up period.
|
30 mg LY3337641 MD
Participants received multiple oral doses of 30 mg LY3337641 tablet once daily for two weeks with a two week follow-up period.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
3
|
9
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
6
|
6
|
6
|
6
|
3
|
9
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
3
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of LY3337641 in Japanese and Caucasian Healthy Participants
Baseline characteristics by cohort
| Measure |
Placebo SD
n=6 Participants
Participants received single oral dose of placebo tablet with a two week follow-up period.
|
5 mg LY3337641 SD
n=6 Participants
Participants received single oral dose of 5 mg LY3337641 tablet with a two week follow-up period.
|
80 mg LY3337641 SD
n=6 Participants
Participants received single oral dose of 80 mg LY3337641 tablet with a two week follow-up period.
|
160 mg LY3337641 SD
n=6 Participants
Participants received single oral dose of 160 mg LY3337641 tablet with a two week follow-up period.
|
Placebo MD
n=3 Participants
Participants received multiple oral doses of placebo tablet once daily for two weeks with a two week follow-up period.
|
30 mg LY3337641 MD
n=9 Participants
Participants received multiple oral doses of 30 mg LY3337641 tablet once daily for two weeks with a two week follow-up period.
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
42.2 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
44.5 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
46.7 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
45.5 years
STANDARD_DEVIATION 12.0 • n=4 Participants
|
36.0 years
STANDARD_DEVIATION 8.9 • n=21 Participants
|
40.8 years
STANDARD_DEVIATION 12.5 • n=10 Participants
|
43.0 years
STANDARD_DEVIATION 11.1 • n=115 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
15 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
21 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
35 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
20 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
16 Participants
n=115 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=10 Participants
|
0 Participants
n=115 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=10 Participants
|
0 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
36 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Up To 31 DaysPopulation: All participants who received at least one dose of LY3337641 or placebo, and have at least one post-dose safety assessment.
Clinically significant events were defined as serious adverse events (SAE). A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Outcome measures
| Measure |
Placebo SD
n=6 Participants
Participants received single oral dose of placebo tablet with a two week follow-up period.
|
5 mg LY3337641 SD
n=6 Participants
Participants received single oral dose of 5 mg LY3337641 tablet with a two week follow-up period.
|
80 mg LY3337641 SD
n=6 Participants
Participants received single oral dose of 80 mg LY3337641 tablet with a two week follow-up period.
|
160 mg LY3337641 SD
n=6 Participants
Participants received single oral dose of 160 mg LY3337641 tablet with a two week follow-up period.
|
Placebo MD
n=3 Participants
Participants received multiple oral doses of placebo tablet once daily for two weeks with a two week follow-up period.
|
30 mg LY3337641 MD
n=9 Participants
Participants received multiple oral doses of 30 mg LY3337641 tablet once daily for two weeks with a two week follow-up period.
|
|---|---|---|---|---|---|---|
|
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
|
SECONDARY outcome
Timeframe: MD: Day 1 pre-dose, 0.25,0.5,1,2,3,4,6,8,10,12 and 24 hours post-dose,Day 15 pre-dose,0.25,0.5,1,2,3,4,6,8,10,12,24,36,48,96,168,240 and 336 hours post-dose. SD: pre-dose, 0.25,0.5,1,2,3,4,6,8,10,12,24,36,48,168 and 336 hours post-dosePopulation: All participants who received at least 1 dose of LY3337641 and have evaluable PK data.
Cmax of LY3337641 was evaluated.
Outcome measures
| Measure |
Placebo SD
n=6 Participants
Participants received single oral dose of placebo tablet with a two week follow-up period.
|
5 mg LY3337641 SD
n=9 Participants
Participants received single oral dose of 5 mg LY3337641 tablet with a two week follow-up period.
|
80 mg LY3337641 SD
n=6 Participants
Participants received single oral dose of 80 mg LY3337641 tablet with a two week follow-up period.
|
160 mg LY3337641 SD
n=6 Participants
Participants received single oral dose of 160 mg LY3337641 tablet with a two week follow-up period.
|
Placebo MD
n=9 Participants
Participants received multiple oral doses of placebo tablet once daily for two weeks with a two week follow-up period.
|
30 mg LY3337641 MD
Participants received multiple oral doses of 30 mg LY3337641 tablet once daily for two weeks with a two week follow-up period.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of LY3337641
|
11.5 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 56
|
56.5 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 44
|
186 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 25
|
358 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 37
|
65.8 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 54
|
—
|
SECONDARY outcome
Timeframe: MD: Day 1 pre-dose, 0.25,0.5,1,2,3,4,6,8,10,12 and 24 hours post-dose,Day 15 pre-dose,0.25,0.5,1,2,3,4,6,8,10,12 and 24 hours post-dose. SD: pre-dose, 0.25,0.5,1,2,3,4,6,8,10,12 and 24 hours post-dosePopulation: All participants who received at least one dose of LY3337641 and have evaluable PK data
AUC from zero to 24-hour of LY3337641 was evaluated.
Outcome measures
| Measure |
Placebo SD
n=6 Participants
Participants received single oral dose of placebo tablet with a two week follow-up period.
|
5 mg LY3337641 SD
n=9 Participants
Participants received single oral dose of 5 mg LY3337641 tablet with a two week follow-up period.
|
80 mg LY3337641 SD
n=6 Participants
Participants received single oral dose of 80 mg LY3337641 tablet with a two week follow-up period.
|
160 mg LY3337641 SD
n=6 Participants
Participants received single oral dose of 160 mg LY3337641 tablet with a two week follow-up period.
|
Placebo MD
n=9 Participants
Participants received multiple oral doses of placebo tablet once daily for two weeks with a two week follow-up period.
|
30 mg LY3337641 MD
Participants received multiple oral doses of 30 mg LY3337641 tablet once daily for two weeks with a two week follow-up period.
|
|---|---|---|---|---|---|---|
|
PK: Area Under the Serum Concentration-Time Curve From Time Zero to 24 Hours (AUC[0-24]) of LY3337641
|
84.8 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 58
|
276 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 59
|
1040 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 26
|
2100 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 47
|
368 nanogram*hour per milliliter (ng*hr/mL)
Geometric Coefficient of Variation 65
|
—
|
SECONDARY outcome
Timeframe: MD: Day 1 pre-dose, 0.25,0.5,1,2,3,4,6,8,10,12 and 24 hours post-dose,Day 15 pre-dose,0.25,0.5,1,2,3,4,6,8,10,12,24,36,48,96,168,240 and 336 hours post-dose. SD: pre-dose, 0.25,0.5,1,2,3,4,6,8,10,12,24,36,48,168 and 336 hours post-dosePopulation: All participants who received at least one dose of LY3337641 and have evaluable PK data.
AUC from zero to infinity of LY3337641 was evaluated. For 30mg LY3337641 MD Day 1, pharmacokinetic data up to 24-hour post-dose were used for pharmacokinetic parameters calculation.
Outcome measures
| Measure |
Placebo SD
n=6 Participants
Participants received single oral dose of placebo tablet with a two week follow-up period.
|
5 mg LY3337641 SD
n=9 Participants
Participants received single oral dose of 5 mg LY3337641 tablet with a two week follow-up period.
|
80 mg LY3337641 SD
n=6 Participants
Participants received single oral dose of 80 mg LY3337641 tablet with a two week follow-up period.
|
160 mg LY3337641 SD
n=6 Participants
Participants received single oral dose of 160 mg LY3337641 tablet with a two week follow-up period.
|
Placebo MD
n=9 Participants
Participants received multiple oral doses of placebo tablet once daily for two weeks with a two week follow-up period.
|
30 mg LY3337641 MD
Participants received multiple oral doses of 30 mg LY3337641 tablet once daily for two weeks with a two week follow-up period.
|
|---|---|---|---|---|---|---|
|
PK: Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3337641
|
92.0 ng*hr/mL
Geometric Coefficient of Variation 62
|
283 ng*hr/mL
Geometric Coefficient of Variation 61
|
1060 ng*hr/mL
Geometric Coefficient of Variation 27
|
2150 ng*hr/mL
Geometric Coefficient of Variation 48
|
382 ng*hr/mL
Geometric Coefficient of Variation 68
|
—
|
Adverse Events
Placebo SD
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
5 mg LY3337641 SD
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
80 mg LY3337641 SD
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
160 mg LY3337641 SD
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo MD
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
30 mg LY3337641 MD
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo SD
n=6 participants at risk
Participants received single oral dose of placebo tablet with a two week follow-up period.
|
5 mg LY3337641 SD
n=6 participants at risk
Participants received single oral dose of 5 mg LY3337641 tablet with a two week follow-up period.
|
80 mg LY3337641 SD
n=6 participants at risk
Participants received single oral dose of 80 mg LY3337641 tablet with a two week follow-up period.
|
160 mg LY3337641 SD
n=6 participants at risk
Participants received single oral dose of 160 mg LY3337641 tablet with a two week follow-up period.
|
Placebo MD
n=3 participants at risk
Participants received multiple oral doses of placebo tablet once daily for two weeks with a two week follow-up period.
|
30 mg LY3337641 MD
n=9 participants at risk
Participants received multiple oral doses of 30 mg LY3337641 tablet once daily for two weeks with a two week follow-up period.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
33.3%
1/3 • Number of events 1 • Up To 31 Days
All enrolled participants.
|
0.00%
0/9 • Up To 31 Days
All enrolled participants.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
66.7%
2/3 • Number of events 2 • Up To 31 Days
All enrolled participants.
|
55.6%
5/9 • Number of events 5 • Up To 31 Days
All enrolled participants.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
33.3%
1/3 • Number of events 1 • Up To 31 Days
All enrolled participants.
|
11.1%
1/9 • Number of events 2 • Up To 31 Days
All enrolled participants.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
33.3%
1/3 • Number of events 1 • Up To 31 Days
All enrolled participants.
|
11.1%
1/9 • Number of events 1 • Up To 31 Days
All enrolled participants.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/3 • Up To 31 Days
All enrolled participants.
|
11.1%
1/9 • Number of events 1 • Up To 31 Days
All enrolled participants.
|
|
General disorders
Fatigue
|
16.7%
1/6 • Number of events 1 • Up To 31 Days
All enrolled participants.
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/3 • Up To 31 Days
All enrolled participants.
|
0.00%
0/9 • Up To 31 Days
All enrolled participants.
|
|
General disorders
Medical device site dermatitis
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
16.7%
1/6 • Number of events 1 • Up To 31 Days
All enrolled participants.
|
0.00%
0/3 • Up To 31 Days
All enrolled participants.
|
0.00%
0/9 • Up To 31 Days
All enrolled participants.
|
|
General disorders
Pain
|
16.7%
1/6 • Number of events 1 • Up To 31 Days
All enrolled participants.
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/3 • Up To 31 Days
All enrolled participants.
|
0.00%
0/9 • Up To 31 Days
All enrolled participants.
|
|
General disorders
Vessel puncture site haemorrhage
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
33.3%
1/3 • Number of events 2 • Up To 31 Days
All enrolled participants.
|
0.00%
0/9 • Up To 31 Days
All enrolled participants.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
16.7%
1/6 • Number of events 1 • Up To 31 Days
All enrolled participants.
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/3 • Up To 31 Days
All enrolled participants.
|
0.00%
0/9 • Up To 31 Days
All enrolled participants.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/3 • Up To 31 Days
All enrolled participants.
|
11.1%
1/9 • Number of events 1 • Up To 31 Days
All enrolled participants.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/3 • Up To 31 Days
All enrolled participants.
|
11.1%
1/9 • Number of events 1 • Up To 31 Days
All enrolled participants.
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Number of events 1 • Up To 31 Days
All enrolled participants.
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
33.3%
1/3 • Number of events 1 • Up To 31 Days
All enrolled participants.
|
11.1%
1/9 • Number of events 2 • Up To 31 Days
All enrolled participants.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/3 • Up To 31 Days
All enrolled participants.
|
11.1%
1/9 • Number of events 1 • Up To 31 Days
All enrolled participants.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/3 • Up To 31 Days
All enrolled participants.
|
11.1%
1/9 • Number of events 1 • Up To 31 Days
All enrolled participants.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
33.3%
1/3 • Number of events 1 • Up To 31 Days
All enrolled participants.
|
0.00%
0/9 • Up To 31 Days
All enrolled participants.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
16.7%
1/6 • Number of events 1 • Up To 31 Days
All enrolled participants.
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
16.7%
1/6 • Number of events 1 • Up To 31 Days
All enrolled participants.
|
0.00%
0/3 • Up To 31 Days
All enrolled participants.
|
0.00%
0/9 • Up To 31 Days
All enrolled participants.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/3 • Up To 31 Days
All enrolled participants.
|
11.1%
1/9 • Number of events 1 • Up To 31 Days
All enrolled participants.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/3 • Up To 31 Days
All enrolled participants.
|
11.1%
1/9 • Number of events 1 • Up To 31 Days
All enrolled participants.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/3 • Up To 31 Days
All enrolled participants.
|
11.1%
1/9 • Number of events 2 • Up To 31 Days
All enrolled participants.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
33.3%
1/3 • Number of events 3 • Up To 31 Days
All enrolled participants.
|
11.1%
1/9 • Number of events 1 • Up To 31 Days
All enrolled participants.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
0.00%
0/6 • Up To 31 Days
All enrolled participants.
|
33.3%
1/3 • Number of events 1 • Up To 31 Days
All enrolled participants.
|
0.00%
0/9 • Up To 31 Days
All enrolled participants.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60