Trial Outcomes & Findings for A Study of LY3154885 in Healthy Participants (NCT NCT04014361)
NCT ID: NCT04014361
Last Updated: 2024-03-12
Results Overview
An SAE is any AE from this study that results in one of the following: death, initial or prolonged inpatient hospitalization, a life-threatening experience (that is, immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect, important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
36 participants
Primary outcome timeframe
Baseline through Study Completion (Up to 5 Months)
Results posted on
2024-03-12
Participant Flow
Participant milestones
| Measure |
Part A: Cohort 1, Sequence 1 (Placebo, 100 mg LY3154885, 375 mg LY3154885)
Period 1:
Participants received Placebo administered orally on Day 1.
Period 2:
Participants received 100 milligrams (mg) LY3154885 administered orally on Day 1.
Period 3:
Participants received 375 mg LY3154885 administered orally on Day 1.
|
Part A: Cohort 1, Sequence 2 (15 mg LY3154885, Placebo, 375 mg LY3154885)
Period 1:
Participants received 15 mg LY3154885 administered orally on Day 1.
Period 2:
Participants received Placebo administered orally on Day 1
Period 3:
Participants received 375 mg LY3154885 administered orally on Day 1.
|
Part A: Cohort 1, Sequence 3 (15 mg LY3154885, 100 mg LY3154885, Placebo)
Period 1:
Participants received 15 mg LY3154885 administered orally on Day 1.
Period 2:
Participants received 100 mg LY3154885 administered orally on Day 1.
Period 3:
Participants received Placebo administered orally on Day 1.
|
Part A: Cohort 2, Sequence 1 (45 mg LY3154885, 200 mg LY3154885, Placebo)
Period 1:
Participants received 45 mg LY3154885 administered orally on Day 1.
Period 2:
Participants received 200 mg LY3154885 administered orally on Day 1.
Period 3:
Participants received Placebo administered orally on Day 1.
|
Part A: Cohort 2, Sequence 2 (Placebo, 200 mg LY3154885, 300 mg LY3154885)
Period 1:
Participants received Placebo administered orally on Day 1.
Period 2:
Participants received 200 mg LY3154885 administered orally on Day 1.
Period 3:
Participants received 300 mg LY3154885 administered orally on Day 1.
|
Part A: Cohort 2, Sequence 3 (45 mg LY3154885, Placebo, 300 mg LY3154885)
Period 1:
Participants received 45 mg LY3154885 administered orally on Day 1.
Period 2:
Participants received Placebo administered orally on Day 1.
Period 3:
Participants received 300 mg LY3154885 administered orally on Day 1
|
Part B: 45 LY3154885 + 200 mg Itraconazole
Period 1:
Participants received 45 mg LY3154885 administered orally.
Period 2:
Participants received 200 mg Itraconazole administered orally on 10 consecutive days and then 45 mg LY3154885 co-administered with 200 mg itraconazole orally.
|
Part B: Placebo + 200 mg Itraconazole
Period 1:
Participants received placebo administered orally.
Period 2:
Participants received 200 mg Itraconazole administered orally on 10 consecutive days and then placebo co-administered with 200 mg itraconazole orally.
|
|---|---|---|---|---|---|---|---|---|
|
Period 1
STARTED
|
4
|
4
|
4
|
4
|
4
|
4
|
9
|
3
|
|
Period 1
Received at Least One Dose of Study Drug
|
4
|
4
|
4
|
4
|
4
|
4
|
9
|
3
|
|
Period 1
COMPLETED
|
4
|
4
|
4
|
4
|
4
|
4
|
9
|
3
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout 1 (7 Days)
STARTED
|
4
|
4
|
4
|
4
|
4
|
4
|
9
|
3
|
|
Washout 1 (7 Days)
COMPLETED
|
4
|
4
|
4
|
4
|
4
|
4
|
9
|
3
|
|
Washout 1 (7 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2
STARTED
|
4
|
4
|
4
|
4
|
4
|
4
|
9
|
3
|
|
Period 2
COMPLETED
|
4
|
4
|
4
|
3
|
4
|
4
|
9
|
3
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Washout 2 (7 Days)
STARTED
|
4
|
4
|
4
|
3
|
4
|
4
|
0
|
0
|
|
Washout 2 (7 Days)
COMPLETED
|
4
|
4
|
4
|
3
|
4
|
4
|
0
|
0
|
|
Washout 2 (7 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 3
STARTED
|
4
|
4
|
4
|
3
|
4
|
4
|
0
|
0
|
|
Period 3
COMPLETED
|
4
|
4
|
4
|
3
|
4
|
4
|
0
|
0
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part A: Cohort 1, Sequence 1 (Placebo, 100 mg LY3154885, 375 mg LY3154885)
Period 1:
Participants received Placebo administered orally on Day 1.
Period 2:
Participants received 100 milligrams (mg) LY3154885 administered orally on Day 1.
Period 3:
Participants received 375 mg LY3154885 administered orally on Day 1.
|
Part A: Cohort 1, Sequence 2 (15 mg LY3154885, Placebo, 375 mg LY3154885)
Period 1:
Participants received 15 mg LY3154885 administered orally on Day 1.
Period 2:
Participants received Placebo administered orally on Day 1
Period 3:
Participants received 375 mg LY3154885 administered orally on Day 1.
|
Part A: Cohort 1, Sequence 3 (15 mg LY3154885, 100 mg LY3154885, Placebo)
Period 1:
Participants received 15 mg LY3154885 administered orally on Day 1.
Period 2:
Participants received 100 mg LY3154885 administered orally on Day 1.
Period 3:
Participants received Placebo administered orally on Day 1.
|
Part A: Cohort 2, Sequence 1 (45 mg LY3154885, 200 mg LY3154885, Placebo)
Period 1:
Participants received 45 mg LY3154885 administered orally on Day 1.
Period 2:
Participants received 200 mg LY3154885 administered orally on Day 1.
Period 3:
Participants received Placebo administered orally on Day 1.
|
Part A: Cohort 2, Sequence 2 (Placebo, 200 mg LY3154885, 300 mg LY3154885)
Period 1:
Participants received Placebo administered orally on Day 1.
Period 2:
Participants received 200 mg LY3154885 administered orally on Day 1.
Period 3:
Participants received 300 mg LY3154885 administered orally on Day 1.
|
Part A: Cohort 2, Sequence 3 (45 mg LY3154885, Placebo, 300 mg LY3154885)
Period 1:
Participants received 45 mg LY3154885 administered orally on Day 1.
Period 2:
Participants received Placebo administered orally on Day 1.
Period 3:
Participants received 300 mg LY3154885 administered orally on Day 1
|
Part B: 45 LY3154885 + 200 mg Itraconazole
Period 1:
Participants received 45 mg LY3154885 administered orally.
Period 2:
Participants received 200 mg Itraconazole administered orally on 10 consecutive days and then 45 mg LY3154885 co-administered with 200 mg itraconazole orally.
|
Part B: Placebo + 200 mg Itraconazole
Period 1:
Participants received placebo administered orally.
Period 2:
Participants received 200 mg Itraconazole administered orally on 10 consecutive days and then placebo co-administered with 200 mg itraconazole orally.
|
|---|---|---|---|---|---|---|---|---|
|
Period 2
Physician Decision
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Study of LY3154885 in Healthy Participants
Baseline characteristics by cohort
| Measure |
Part A: Cohort 1, Sequence 1 (Placebo, 100 mg LY3154885, 375 mg LY3154885)
n=4 Participants
Period 1:
Participants received Placebo administered orally on Day 1.
Period 2:
Participants received 100 mg LY3154885 administered orally on Day 1.
Period 3:
Participants received 375 mg LY3154885 administered orally on Day 1.
|
Part A: Cohort 1, Sequence 2 (15 mg LY3154885, Placebo, 375 mg LY3154885)
n=4 Participants
Period 1:
Participants received 15 mg LY3154885 administered orally on Day 1.
Period 2:
Participants received Placebo administered orally on Day 1
Period 3:
Participants received 375 mg LY3154885 administered orally on Day 1.
|
Part A: Cohort 1, Sequence 3 (15 mg LY3154885, 100 mg LY3154885, Placebo)
n=4 Participants
Period 1:
Participants received 15 mg LY3154885 administered orally on Day 1.
Period 2:
Participants received 100 mg LY3154885 administered orally on Day 1.
Period 3:
Participants received Placebo administered orally on Day 1.
|
Part A: Cohort 2, Sequence 1 (45 mg LY3154885, 200 mg LY3154885, Placebo)
n=4 Participants
Period 1:
Participants received 45 mg LY3154885 administered orally on Day 1.
Period 2:
Participants received 200 mg LY3154885 administered orally on Day 1.
Period 3:
Participants received Placebo administered orally on Day 1.
|
Part A: Cohort 2, Sequence 2 (Placebo, 200 mg LY3154885, 300 mg LY3154885)
n=4 Participants
Period 1:
Participants received Placebo administered orally on Day 1.
Period 2:
Participants received 200 mg LY3154885 administered orally on Day 1.
Period 3:
Participants received 300 mg LY3154885 administered orally on Day 1.
|
Part A: Cohort 2, Sequence 3 (45 mg LY3154885, Placebo, 300 mg LY3154885)
n=4 Participants
Period 1:
Participants received 45 mg LY3154885 administered orally on Day 1.
Period 2:
Participants received Placebo administered orally on Day 1.
Period 3:
Participants received 300 mg LY3154885 administered orally on Day 1
|
Part B: 45 LY3154885 + 200 mg Itraconazole
n=9 Participants
Period 1:
Participants received 45 mg LY3154885 administered orally.
Period 2:
Participants received 200 mg Itraconazole administered orally on 10 consecutive days and then 45 mg LY3154885 co-administered with 200 mg itraconazole orally.
|
Part B: Placebo + 200 mg Itraconazole
n=3 Participants
Period 1:
Participants received placebo administered orally.
Period 2:
Participants received 200 mg Itraconazole administered orally on 10 consecutive days and then placebo co-administered with 200 mg itraconazole orally
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
3 Participants
n=40 Participants
|
36 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
9 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
3 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
3 Participants
n=40 Participants
|
27 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
1 Participants
n=40 Participants
|
9 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
2 Participants
n=40 Participants
|
27 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
1 Participants
n=40 Participants
|
20 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
2 Participants
n=40 Participants
|
16 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
4 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
3 Participants
n=40 Participants
|
36 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline through Study Completion (Up to 5 Months)Population: All participants who received at least one dose of study drug.
An SAE is any AE from this study that results in one of the following: death, initial or prolonged inpatient hospitalization, a life-threatening experience (that is, immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect, important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.
Outcome measures
| Measure |
Part A Placebo
n=23 Participants
Participants received Placebo administered orally.
|
Part A 15 mg LY3154885
n=8 Participants
Participants received 15 mg LY3154885 administered orally.
|
Part A 45 mg LY3154885
n=8 Participants
Participants received 45 mg LY3154885 administered orally.
|
Part A 100 mg LY3154885
n=8 Participants
Participants received 100 mg LY3154885 administered orally.
|
Part A 200 mg LY3154885
n=8 Participants
Participants received 200 mg LY3154885 administered orally.
|
Part A 300 mg LY3154885
n=8 Participants
Participants received 300 mg LY3154885 administered orally.
|
Part A 375 mg LY3154885
n=8 Participants
Participants received 375 mg LY3154885 administered orally.
|
Part B: 45 LY3154885 + 200 mg Itraconazole
n=9 Participants
Period 1:
Participants received 45 mg LY3154885 administered orally.
Period 2:
Participants received 200 mg Itraconazole administered orally on 10 consecutive days and then 45 mg LY3154885 co-administered with 200 mg itraconazole orally.
|
Part B: Placebo + 200 mg Itraconazole
n=3 Participants
Period 1:
Participants received placebo administered orally.
Period 2:
Participants received 200 mg Itraconazole administered orally on 10 consecutive days and then placebo co-administered with 200 mg itraconazole orally.
|
|---|---|---|---|---|---|---|---|---|---|
|
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
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post dosePopulation: Part A: All participants who received at least one dose of study drug and had evaluable PK data.
Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3154885
Outcome measures
| Measure |
Part A Placebo
n=8 Participants
Participants received Placebo administered orally.
|
Part A 15 mg LY3154885
n=7 Participants
Participants received 15 mg LY3154885 administered orally.
|
Part A 45 mg LY3154885
n=8 Participants
Participants received 45 mg LY3154885 administered orally.
|
Part A 100 mg LY3154885
n=7 Participants
Participants received 100 mg LY3154885 administered orally.
|
Part A 200 mg LY3154885
n=8 Participants
Participants received 200 mg LY3154885 administered orally.
|
Part A 300 mg LY3154885
n=8 Participants
Participants received 300 mg LY3154885 administered orally.
|
Part A 375 mg LY3154885
Participants received 375 mg LY3154885 administered orally.
|
Part B: 45 LY3154885 + 200 mg Itraconazole
Period 1:
Participants received 45 mg LY3154885 administered orally.
Period 2:
Participants received 200 mg Itraconazole administered orally on 10 consecutive days and then 45 mg LY3154885 co-administered with 200 mg itraconazole orally.
|
Part B: Placebo + 200 mg Itraconazole
Period 1:
Participants received placebo administered orally.
Period 2:
Participants received 200 mg Itraconazole administered orally on 10 consecutive days and then placebo co-administered with 200 mg itraconazole orally.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3154885
|
95.7 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 35
|
156 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 43
|
519 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 39
|
763 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 69
|
1180 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 38
|
1360 Nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 43
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post dose; Day 14: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 60, 72 and 96 hours post dose.Population: Part B: All participants who received at least one dose of study drug and had evaluable PK data.
Part B: PK: Maximum Concentration (Cmax) of LY3154885
Outcome measures
| Measure |
Part A Placebo
n=9 Participants
Participants received Placebo administered orally.
|
Part A 15 mg LY3154885
n=9 Participants
Participants received 15 mg LY3154885 administered orally.
|
Part A 45 mg LY3154885
Participants received 45 mg LY3154885 administered orally.
|
Part A 100 mg LY3154885
Participants received 100 mg LY3154885 administered orally.
|
Part A 200 mg LY3154885
Participants received 200 mg LY3154885 administered orally.
|
Part A 300 mg LY3154885
Participants received 300 mg LY3154885 administered orally.
|
Part A 375 mg LY3154885
Participants received 375 mg LY3154885 administered orally.
|
Part B: 45 LY3154885 + 200 mg Itraconazole
Period 1:
Participants received 45 mg LY3154885 administered orally.
Period 2:
Participants received 200 mg Itraconazole administered orally on 10 consecutive days and then 45 mg LY3154885 co-administered with 200 mg itraconazole orally.
|
Part B: Placebo + 200 mg Itraconazole
Period 1:
Participants received placebo administered orally.
Period 2:
Participants received 200 mg Itraconazole administered orally on 10 consecutive days and then placebo co-administered with 200 mg itraconazole orally.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part B: PK: Maximum Concentration (Cmax) of LY3154885
LY3154885 Single Dose (Day 1)
|
219 ng/mL
Geometric Coefficient of Variation 52
|
NA ng/mL
Geometric Coefficient of Variation NA
Reporting only LY3154885 Single Dose (Day 1) data on this row
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: PK: Maximum Concentration (Cmax) of LY3154885
LY3154885 Single Dose + Itraconazole QD (Day 14)
|
NA ng/mL
Geometric Coefficient of Variation NA
Reporting only LY3154885 Single Dose + Itraconazole QD (Day 14) on this row.
|
408 ng/mL
Geometric Coefficient of Variation 33
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post dosePopulation: Part A: All participants who received at least one dose of study drug and had evaluable PK data.
Part A, PK: Time to Maximum Plasma Concentration (Tmax) LY3154885
Outcome measures
| Measure |
Part A Placebo
n=8 Participants
Participants received Placebo administered orally.
|
Part A 15 mg LY3154885
n=7 Participants
Participants received 15 mg LY3154885 administered orally.
|
Part A 45 mg LY3154885
n=8 Participants
Participants received 45 mg LY3154885 administered orally.
|
Part A 100 mg LY3154885
n=7 Participants
Participants received 100 mg LY3154885 administered orally.
|
Part A 200 mg LY3154885
n=8 Participants
Participants received 200 mg LY3154885 administered orally.
|
Part A 300 mg LY3154885
n=8 Participants
Participants received 300 mg LY3154885 administered orally.
|
Part A 375 mg LY3154885
Participants received 375 mg LY3154885 administered orally.
|
Part B: 45 LY3154885 + 200 mg Itraconazole
Period 1:
Participants received 45 mg LY3154885 administered orally.
Period 2:
Participants received 200 mg Itraconazole administered orally on 10 consecutive days and then 45 mg LY3154885 co-administered with 200 mg itraconazole orally.
|
Part B: Placebo + 200 mg Itraconazole
Period 1:
Participants received placebo administered orally.
Period 2:
Participants received 200 mg Itraconazole administered orally on 10 consecutive days and then placebo co-administered with 200 mg itraconazole orally.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part A, PK: Time to Maximum Plasma Concentration (Tmax) LY3154885
|
3.00 Hours
Interval 2.0 to 3.08
|
4.00 Hours
Interval 2.0 to 5.0
|
3.01 Hours
Interval 2.0 to 5.05
|
3.00 Hours
Interval 2.0 to 6.05
|
3.00 Hours
Interval 2.0 to 6.0
|
3.02 Hours
Interval 2.0 to 5.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post dose; Day 14: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 60, 72 and 96 hours post dose.Population: All participants who received at least one dose of study drug and had evaluable PK data.
Outcome measures
| Measure |
Part A Placebo
n=9 Participants
Participants received Placebo administered orally.
|
Part A 15 mg LY3154885
n=9 Participants
Participants received 15 mg LY3154885 administered orally.
|
Part A 45 mg LY3154885
Participants received 45 mg LY3154885 administered orally.
|
Part A 100 mg LY3154885
Participants received 100 mg LY3154885 administered orally.
|
Part A 200 mg LY3154885
Participants received 200 mg LY3154885 administered orally.
|
Part A 300 mg LY3154885
Participants received 300 mg LY3154885 administered orally.
|
Part A 375 mg LY3154885
Participants received 375 mg LY3154885 administered orally.
|
Part B: 45 LY3154885 + 200 mg Itraconazole
Period 1:
Participants received 45 mg LY3154885 administered orally.
Period 2:
Participants received 200 mg Itraconazole administered orally on 10 consecutive days and then 45 mg LY3154885 co-administered with 200 mg itraconazole orally.
|
Part B: Placebo + 200 mg Itraconazole
Period 1:
Participants received placebo administered orally.
Period 2:
Participants received 200 mg Itraconazole administered orally on 10 consecutive days and then placebo co-administered with 200 mg itraconazole orally.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part B, PK: Time to Maximum Plasma Concentration (Tmax) LY3154885
LY3154885 Single Dose (Day 1)
|
2.00 Hours
Interval 1.0 to 8.0
|
NA Hours
Reporting only LY3154885 Single Dose (Day 1) data on this row.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B, PK: Time to Maximum Plasma Concentration (Tmax) LY3154885
LY3154885 Single Dose + Itraconazole QD (Day 14)
|
NA Hours
Reporting only LY3154885 Single Dose + Itraconazole QD (Day 14) on this row.
|
6.00 Hours
Interval 3.0 to 8.03
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 hours post dosePopulation: Part A: All participants who received at least one dose of study drug who had evaluable PK data.
Part A, PK: Area Under the Concentration Versus Time Curve to Infinity \[AUC(0-∞)\] of LY3154885
Outcome measures
| Measure |
Part A Placebo
n=8 Participants
Participants received Placebo administered orally.
|
Part A 15 mg LY3154885
n=7 Participants
Participants received 15 mg LY3154885 administered orally.
|
Part A 45 mg LY3154885
n=8 Participants
Participants received 45 mg LY3154885 administered orally.
|
Part A 100 mg LY3154885
n=7 Participants
Participants received 100 mg LY3154885 administered orally.
|
Part A 200 mg LY3154885
n=8 Participants
Participants received 200 mg LY3154885 administered orally.
|
Part A 300 mg LY3154885
n=8 Participants
Participants received 300 mg LY3154885 administered orally.
|
Part A 375 mg LY3154885
Participants received 375 mg LY3154885 administered orally.
|
Part B: 45 LY3154885 + 200 mg Itraconazole
Period 1:
Participants received 45 mg LY3154885 administered orally.
Period 2:
Participants received 200 mg Itraconazole administered orally on 10 consecutive days and then 45 mg LY3154885 co-administered with 200 mg itraconazole orally.
|
Part B: Placebo + 200 mg Itraconazole
Period 1:
Participants received placebo administered orally.
Period 2:
Participants received 200 mg Itraconazole administered orally on 10 consecutive days and then placebo co-administered with 200 mg itraconazole orally.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part A, PK: Area Under the Concentration Versus Time Curve to Infinity [AUC(0-∞)] of LY3154885
|
1290 nanogram hour per milliliter (h*ng/mL)
Geometric Coefficient of Variation 53
|
2710 nanogram hour per milliliter (h*ng/mL)
Geometric Coefficient of Variation 48
|
8410 nanogram hour per milliliter (h*ng/mL)
Geometric Coefficient of Variation 59
|
14900 nanogram hour per milliliter (h*ng/mL)
Geometric Coefficient of Variation 96
|
30900 nanogram hour per milliliter (h*ng/mL)
Geometric Coefficient of Variation 82
|
28600 nanogram hour per milliliter (h*ng/mL)
Geometric Coefficient of Variation 48
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36 and 48 hours post dose; Day 14: Predose, 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 60, 72 and 96 hours post dose.Population: Part B: All participants who received at least one dose of study drug who had evaluable PK data.
Part B, PK: Area Under the Concentration Versus Time Curve to Infinity \[AUC(0-∞)\] of LY3154885
Outcome measures
| Measure |
Part A Placebo
n=9 Participants
Participants received Placebo administered orally.
|
Part A 15 mg LY3154885
n=9 Participants
Participants received 15 mg LY3154885 administered orally.
|
Part A 45 mg LY3154885
Participants received 45 mg LY3154885 administered orally.
|
Part A 100 mg LY3154885
Participants received 100 mg LY3154885 administered orally.
|
Part A 200 mg LY3154885
Participants received 200 mg LY3154885 administered orally.
|
Part A 300 mg LY3154885
Participants received 300 mg LY3154885 administered orally.
|
Part A 375 mg LY3154885
Participants received 375 mg LY3154885 administered orally.
|
Part B: 45 LY3154885 + 200 mg Itraconazole
Period 1:
Participants received 45 mg LY3154885 administered orally.
Period 2:
Participants received 200 mg Itraconazole administered orally on 10 consecutive days and then 45 mg LY3154885 co-administered with 200 mg itraconazole orally.
|
Part B: Placebo + 200 mg Itraconazole
Period 1:
Participants received placebo administered orally.
Period 2:
Participants received 200 mg Itraconazole administered orally on 10 consecutive days and then placebo co-administered with 200 mg itraconazole orally.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part B, PK: Area Under the Concentration Versus Time Curve to Infinity [AUC(0-∞)] of LY3154885
LY3154885 Single Dose (Day 1)
|
4510 h*ng/mL
Geometric Coefficient of Variation 54
|
NA h*ng/mL
Geometric Coefficient of Variation NA
Reporting only LY3154885 Single Dose (Day 1) data on this row.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B, PK: Area Under the Concentration Versus Time Curve to Infinity [AUC(0-∞)] of LY3154885
LY3154885 Single Dose + Itraconazole QD (Day 14)
|
NA h*ng/mL
Geometric Coefficient of Variation NA
Reporting only LY3154885 Single Dose + Itraconazole QD (Day 14) on this row
|
16900 h*ng/mL
Geometric Coefficient of Variation 34
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Part A Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part A 15 mg LY3154885
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part A 45 mg LY3154885
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part A 100 mg LY3154885
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part A 200 mg LY3154885
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part A 300 mg LY3154885
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part A 375 mg LY3154885
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part B Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part B 45 mg LY3154885
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Part B 200 mg Itraconazole
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part B 45 mg LY3154885 + 200 mg Itraconazole
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part B Placebo + 200 mg Itraconazole
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part A Placebo
n=23 participants at risk
Participants received Placebo administered orally.
|
Part A 15 mg LY3154885
n=8 participants at risk
Participants received 15 mg LY3154885 administered orally.
|
Part A 45 mg LY3154885
n=8 participants at risk
Participants received 45 mg LY3154885 administered orally.
|
Part A 100 mg LY3154885
n=8 participants at risk
Participants received 100 mg LY3154885 administered orally.
|
Part A 200 mg LY3154885
n=8 participants at risk
Participants received 200 mg LY3154885 administered orally.
|
Part A 300 mg LY3154885
n=8 participants at risk
Participants received 300 mg LY3154885 administered orally.
|
Part A 375 mg LY3154885
n=8 participants at risk
Participants received 375 mg LY3154885 administered orally.
|
Part B Placebo
n=3 participants at risk
Participants received Placebo administered orally.
|
Part B 45 mg LY3154885
n=9 participants at risk
Participants received 45 mg LY3154885 administered orally.
|
Part B 200 mg Itraconazole
n=12 participants at risk
Participants received 200 mg Itraconazole administered orally.
|
Part B 45 mg LY3154885 + 200 mg Itraconazole
n=9 participants at risk
Participants received 45 mg LY3154885 + 200 mg Itraconazole administered orally.
|
Part B Placebo + 200 mg Itraconazole
n=3 participants at risk
Participants received Placebo + 200 mg Itraconazole administered orally.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/23 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
8.3%
1/12 • Number of events 1 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/23 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Energy increased
|
0.00%
0/23 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Feeling jittery
|
0.00%
0/23 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/23 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
4.3%
1/23 • Number of events 1 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/23 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
37.5%
3/8 • Number of events 3 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
4.3%
1/23 • Number of events 1 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
50.0%
4/8 • Number of events 4 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/23 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/8 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
12.5%
1/8 • Number of events 1 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/12 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Baseline Up To 5 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/3 • Baseline Up To 5 Months
All randomized 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