Trial Outcomes & Findings for A Study of LY2409021 in Healthy Participants (NCT NCT02217618)
NCT ID: NCT02217618
Last Updated: 2018-10-29
Results Overview
Area under the concentration versus time curve from zero to infinity (AUC\[0-inf\]) of LY2409021 is presented.
COMPLETED
PHASE1
16 participants
Pre-dose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 144, 192, 264, and 336 hours post-dose
2018-10-29
Participant Flow
Participant milestones
| Measure |
LY2409021
Single oral dose of 20 milligrams (mg) LY2409021.
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
Received Study Drug
|
16
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of LY2409021 in Healthy Participants
Baseline characteristics by cohort
| Measure |
LY2409021
n=16 Participants
Single oral dose of 20 mg LY2409021.
|
|---|---|
|
Age, Continuous
|
48.4 years
STANDARD_DEVIATION 13.3 • n=99 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
16 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Pre-dose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 144, 192, 264, and 336 hours post-dosePopulation: All participants who received a dose of study drug and had evaluable AUC(0-inf) data.
Area under the concentration versus time curve from zero to infinity (AUC\[0-inf\]) of LY2409021 is presented.
Outcome measures
| Measure |
LY2409021
n=16 Participants
Single oral dose of 20 mg LY2409021.
|
|---|---|
|
Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY2409021
|
48100 nanogram*hours per milliliter (ng*h/mL)
Geometric Coefficient of Variation 28
|
PRIMARY outcome
Timeframe: Pre-dose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 144, 192, 264, and 336 hours post-dosePopulation: All participants who received a dose of study drug and had evaluable Cmax data.
Outcome measures
| Measure |
LY2409021
n=16 Participants
Single oral dose of 20 mg LY2409021.
|
|---|---|
|
Pharmacokinetics: Maximum Concentration (Cmax) of LY2409021
|
625 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 29
|
PRIMARY outcome
Timeframe: Pre-dose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 144, 192, 264, and 336 hours post-dosePopulation: All participants who received a dose of study drug and had evaluable Tmax data.
Outcome measures
| Measure |
LY2409021
n=16 Participants
Single oral dose of 20 mg LY2409021.
|
|---|---|
|
Pharmacokinetics: Time to Maximum Observed Drug Concentration (Tmax) of LY2409021
|
8.00 hours
Interval 4.0 to 24.03
|
Adverse Events
LY2409021
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LY2409021
n=16 participants at risk
Single oral dose of 20 mg LY2409021.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
6.2%
1/16 • Number of events 1
|
|
Nervous system disorders
Headache
|
6.2%
1/16 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
6.2%
1/16 • Number of events 1
|
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