Trial Outcomes & Findings for A Study of LY3006072 in Healthy Participants (NCT NCT01640249)
NCT ID: NCT01640249
Last Updated: 2019-08-08
Results Overview
AEs that were considered possibly related to study drug, in the opinion of the investigator, were reported. A summary of serious and all other non-serious AEs, regardless of possible drug relatedness, is located in the Reported Adverse Event module.
TERMINATED
PHASE1
18 participants
Baseline, up to 21 days
2019-08-08
Participant Flow
This was a 2-part (Part A and Part B) crossover study. Part A was a dose-escalation with up to 3-period crossover with 2 alternating cohorts (Cohorts 1 and 2). There was 14 days of washout time between each dose. Part B was not initiated as study was terminated early due to technical factors.
Participant milestones
| Measure |
Cohort 1 (Sequence 1)
Participants received LY3006072 and Placebo capsules as per below dosing schedules.
Period 1: 1 milligrams (mg) LY3006072, Period 2: 10 mg LY3006072 and Period 3: Placebo
|
Cohort 1 (Sequence 2)
Participants received LY3006072 and Placebo capsules as per below dosing schedules.
Period 1: 1 mg LY3006072, Period 2: Placebo, Period 3: 40 mg LY3006072
|
Cohort 1 Sequence 3
Participants received LY3006072 and Placebo capsules as per below dosing schedule.
Period 1: Placebo, Period 2: 10 mg LY3006072 and Period 3: 40 mg LY3006072
|
Cohort 1 Sequence 4
Participants received 1 mg, 10 mg and 40 mg of LY3006072 capsules as per below dosing schedule.
Period 1: 1 mg LY3006072, Period 2: 10 mg LY3006072 and Period 3: 40 mg LY3006072
|
Cohort 2 (Sequence 1)
Participants received Placebo and 20 mg of LY3006072 capsules as per below dosing schedule.
Period 1: Placebo and Period 2: 20 mg LY3006072
|
Cohort 2 (Sequence 2)
Participants received 3 mg and 20 mg of LY3006072 capsules as per below dosing schedule.
Period 1: 3 mg LY3006072 and Period 2: 20 mg LY3006072
|
Cohort 2 (Sequence 3)
Participants received Placebo and 3 mg of LY3006072 capsules as per below dosing schedule.
Period 1: 3 mg LY3006072 and Period 2: Placebo
|
|---|---|---|---|---|---|---|---|
|
Period 1
STARTED
|
3
|
2
|
2
|
2
|
2
|
5
|
2
|
|
Period 1
Received at Least 1 Dose of Study Drug
|
3
|
2
|
2
|
2
|
2
|
5
|
2
|
|
Period 1
COMPLETED
|
2
|
2
|
2
|
2
|
2
|
4
|
2
|
|
Period 1
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Period 2
STARTED
|
2
|
2
|
2
|
2
|
2
|
4
|
2
|
|
Period 2
COMPLETED
|
2
|
2
|
2
|
2
|
2
|
4
|
2
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 3
STARTED
|
2
|
2
|
2
|
2
|
0
|
0
|
0
|
|
Period 3
COMPLETED
|
2
|
2
|
2
|
1
|
0
|
0
|
0
|
|
Period 3
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1 (Sequence 1)
Participants received LY3006072 and Placebo capsules as per below dosing schedules.
Period 1: 1 milligrams (mg) LY3006072, Period 2: 10 mg LY3006072 and Period 3: Placebo
|
Cohort 1 (Sequence 2)
Participants received LY3006072 and Placebo capsules as per below dosing schedules.
Period 1: 1 mg LY3006072, Period 2: Placebo, Period 3: 40 mg LY3006072
|
Cohort 1 Sequence 3
Participants received LY3006072 and Placebo capsules as per below dosing schedule.
Period 1: Placebo, Period 2: 10 mg LY3006072 and Period 3: 40 mg LY3006072
|
Cohort 1 Sequence 4
Participants received 1 mg, 10 mg and 40 mg of LY3006072 capsules as per below dosing schedule.
Period 1: 1 mg LY3006072, Period 2: 10 mg LY3006072 and Period 3: 40 mg LY3006072
|
Cohort 2 (Sequence 1)
Participants received Placebo and 20 mg of LY3006072 capsules as per below dosing schedule.
Period 1: Placebo and Period 2: 20 mg LY3006072
|
Cohort 2 (Sequence 2)
Participants received 3 mg and 20 mg of LY3006072 capsules as per below dosing schedule.
Period 1: 3 mg LY3006072 and Period 2: 20 mg LY3006072
|
Cohort 2 (Sequence 3)
Participants received Placebo and 3 mg of LY3006072 capsules as per below dosing schedule.
Period 1: 3 mg LY3006072 and Period 2: Placebo
|
|---|---|---|---|---|---|---|---|
|
Period 1
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study of LY3006072 in Healthy Participants
Baseline characteristics by cohort
| Measure |
Cohort 2 (Sequence 2)
n=5 Participants
Participants received 3 mg and 20 mg of LY3006072 capsules as per below dosing schedule.
Period 1: 3 mg LY3006072 and Period 2: 20 mg LY3006072
|
Cohort 2 (Sequence 3)
n=2 Participants
Participants received Placebo and 3 mg of LY3006072 capsules as per below dosing schedule.
Period 1: 3 mg LY3006072 and Period 2: Placebo
|
Cohort 1 (Sequence 1)
n=3 Participants
Participants received LY3006072 and Placebo capsules as per below dosing schedules.
Period 1: 1 milligrams (mg) LY3006072, Period 2: 10 mg LY3006072 and Period 3: Placebo
|
Cohort 1 (Sequence 2)
n=2 Participants
Participants received LY3006072 and Placebo capsules as per below dosing schedules.
Period 1: 1 mg LY3006072, Period 2: Placebo, Period 3: 40 mg LY3006072
|
Cohort 1 (Sequence 3)
n=2 Participants
Participants received LY3006072 and Placebo capsules as per below dosing schedule.
Period 1: Placebo, Period 2: 10 mg LY3006072 and Period 3: 40 mg LY3006072
|
Cohort 1 (Sequence 4)
n=2 Participants
Participants received 1 mg, 10 mg and 40 mg of LY3006072 capsules as per below dosing schedule.
Period 1: 1 mg LY3006072, Period 2: 10 mg LY3006072 and Period 3: 40 mg LY3006072
|
Cohort 2 (Sequence 1)
n=2 Participants
Participants received Placebo and 20 mg of LY3006072 capsules as per below dosing schedule.
Period 1: Placebo and Period 2: 20 mg LY3006072
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=6 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
10 Participants
n=6 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
8 Participants
n=6 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
12 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
6 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
18 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
2 Participants
n=6 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
16 Participants
n=6 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=6 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=6 Participants
|
|
Region of Enrollment
United States
|
5 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
18 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Baseline, up to 21 daysPopulation: All randomized participants who received at least one dose of study drug.
AEs that were considered possibly related to study drug, in the opinion of the investigator, were reported. A summary of serious and all other non-serious AEs, regardless of possible drug relatedness, is located in the Reported Adverse Event module.
Outcome measures
| Measure |
Placebo
n=9 Participants
Participants received placebo capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
|
1 mg LY3006072
n=6 Participants
Participants received 1 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
|
3 mg LY3006072
n=6 Participants
Participants received 3 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
|
10 mg LY3006072
n=6 Participants
Participants received 10 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
|
20 mg LY3006072
n=6 Participants
Participants received 20 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
|
40 mg LY3006072
n=6 Participants
Participants received 40 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
|
|---|---|---|---|---|---|---|
|
Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AEs
Serious AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With One or More Drug Related Adverse Events (AEs) or Any Serious AEs
Other Non-Serious AEs
|
0 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Predose, 0.25, 0.5, 1, 2, 3, 5, 8, 12, 16, 24, 36, 48 and 96 hours postdosePopulation: All randomized participants who received at least one dose of study drug and have evaluable PK data.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received placebo capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
|
1 mg LY3006072
n=6 Participants
Participants received 1 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
|
3 mg LY3006072
n=6 Participants
Participants received 3 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
|
10 mg LY3006072
n=6 Participants
Participants received 10 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
|
20 mg LY3006072
n=6 Participants
Participants received 20 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
|
40 mg LY3006072
Participants received 40 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics: Maximum Concentration (Cmax) of LY3006072
|
18.8 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 20
|
57.0 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 12
|
160 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 24
|
263 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 42
|
576 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 31
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.25, 0.5, 1, 2, 3, 5, 8, 12, 16, 24, 36, 48 and 96 hours postdosePopulation: All randomized participants who received at least one dose of study drug and have evaluable PK data.
PK: Area Under the Concentration-Time Curve from Time Zero to Infinity (AUC\[0-inf\] of LY3006072.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants received placebo capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
|
1 mg LY3006072
n=6 Participants
Participants received 1 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
|
3 mg LY3006072
n=6 Participants
Participants received 3 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
|
10 mg LY3006072
n=6 Participants
Participants received 10 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
|
20 mg LY3006072
n=6 Participants
Participants received 20 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
|
40 mg LY3006072
Participants received 40 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3006072
|
1530 nanograms * hours per mL (ng*hr/mL)
Geometric Coefficient of Variation 47
|
4800 nanograms * hours per mL (ng*hr/mL)
Geometric Coefficient of Variation 34
|
14400 nanograms * hours per mL (ng*hr/mL)
Geometric Coefficient of Variation 25
|
24700 nanograms * hours per mL (ng*hr/mL)
Geometric Coefficient of Variation 27
|
65600 nanograms * hours per mL (ng*hr/mL)
Geometric Coefficient of Variation 21
|
—
|
Adverse Events
Placebo
1 mg LY3006072
3 mg LY3006072
10 mg LY3006072
20 mg LY3006072
40 mg LY3006072
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=9 participants at risk
Participants received placebo capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
|
1 mg LY3006072
n=6 participants at risk
Participants received 1 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
|
3 mg LY3006072
n=6 participants at risk
Participants received 3 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
|
10 mg LY3006072
n=6 participants at risk
Participants received 10 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
|
20 mg LY3006072
n=6 participants at risk
Participants received 20 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
|
40 mg LY3006072
n=6 participants at risk
Participants received 40 mg LY3006072 capsule orally with approximately 200 to 300 mL of room temperature water in the morning.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/9 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/9 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/9 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/9 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/9 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/9 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/9 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
|
50.0%
3/6 • Number of events 3 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
|
100.0%
6/6 • Number of events 6 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/9 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up To 21 Days
All randomized participants who received at least one dose of study drug.
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60