Trial Outcomes & Findings for A Study of LY2835219 in Healthy Participants (NCT NCT02059148)
NCT ID: NCT02059148
Last Updated: 2019-01-07
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each period
Results posted on
2019-01-07
Participant Flow
Participant milestones
| Measure |
Sequence 1
Single Oral Dose of 200 mg LY2835219 on 3 Occasions: Standard Meal, Fasted State, High-Fat Meal. Dosing occasions were separated by at least 14 days.
|
Sequence 2
Single Oral Dose of 200 mg LY2835219 on 3 Occasions: Standard Meal, High-Fat Meal, Fasted State. Dosing occasions were separated by at least 14 days.
|
Sequence 3
Single Oral Dose of 200 mg LY2835219 on 3 Occasions: Fasted State, High-Fat Meal, Standard Meal. Dosing occasions were separated by at least 14 days.
|
Sequence 4
Single oral dose of 200 mg LY2835219 on 3 Occasions: Fasted State, Standard Meal, High-Fat Meal. Dosing occasions were separated by at least 14 days.
|
Sequence 5
Single oral dose of 200 mg LY2835219 on 3 Occasions: High-Fat Meal, Fasted State, Standard Meal. Dosing occasions were separated by at least 14 days.
|
Sequence 6
Single Oral Dose of 200 mg LY2835219 on 3 Occasions: High-Fat Meal, Standard Meal, Fasted State. Dosing occasions were separated by at least 14 days.
|
|---|---|---|---|---|---|---|
|
Treatment 1
STARTED
|
4
|
4
|
4
|
4
|
4
|
4
|
|
Treatment 1
COMPLETED
|
4
|
4
|
4
|
4
|
4
|
3
|
|
Treatment 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Treatment 2
STARTED
|
4
|
4
|
4
|
4
|
4
|
3
|
|
Treatment 2
COMPLETED
|
4
|
4
|
4
|
4
|
4
|
3
|
|
Treatment 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment 3
STARTED
|
4
|
4
|
4
|
4
|
4
|
3
|
|
Treatment 3
COMPLETED
|
4
|
4
|
4
|
4
|
4
|
3
|
|
Treatment 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Sequence 1
Single Oral Dose of 200 mg LY2835219 on 3 Occasions: Standard Meal, Fasted State, High-Fat Meal. Dosing occasions were separated by at least 14 days.
|
Sequence 2
Single Oral Dose of 200 mg LY2835219 on 3 Occasions: Standard Meal, High-Fat Meal, Fasted State. Dosing occasions were separated by at least 14 days.
|
Sequence 3
Single Oral Dose of 200 mg LY2835219 on 3 Occasions: Fasted State, High-Fat Meal, Standard Meal. Dosing occasions were separated by at least 14 days.
|
Sequence 4
Single oral dose of 200 mg LY2835219 on 3 Occasions: Fasted State, Standard Meal, High-Fat Meal. Dosing occasions were separated by at least 14 days.
|
Sequence 5
Single oral dose of 200 mg LY2835219 on 3 Occasions: High-Fat Meal, Fasted State, Standard Meal. Dosing occasions were separated by at least 14 days.
|
Sequence 6
Single Oral Dose of 200 mg LY2835219 on 3 Occasions: High-Fat Meal, Standard Meal, Fasted State. Dosing occasions were separated by at least 14 days.
|
|---|---|---|---|---|---|---|
|
Treatment 1
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study of LY2835219 in Healthy Participants
Baseline characteristics by cohort
| Measure |
All Study Participants
n=24 Participants
Single Oral Dose of 200 mg LY2835219 on 3 Occasions: Standard Meal, Fasted State, High-Fat Meal. Dosing occasions were separated by at least 14 days.
|
|---|---|
|
Age, Continuous
|
53.9 Years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each periodPopulation: All randomized participants receiving at least one dose of the investigational product.
Outcome measures
| Measure |
LY2835219 Fasted
n=23 Participants
Single oral dose of LY2835219 given with no food in one of three periods.
LY2835219: Administered orally.
|
LY2835219 High-Fat
n=24 Participants
Single oral dose of LY2835219 given with a high fat meal in one of three periods.
LY2835219: Administered orally.
|
LY2835219 High-Fat
Single oral dose of LY2835219 given with a high fat meal in one of three periods.
LY2835219: Administered orally.
|
|---|---|---|---|
|
Pharmacokinetics: Maximum Concentration (Cmax) of LY2835219 Fasted vs. High-Fat Arms
|
111 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 61
|
137 nanogram/milliliter (ng/mL)
Geometric Coefficient of Variation 52
|
—
|
PRIMARY outcome
Timeframe: Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each periodPopulation: All randomized participants receiving at least one dose of the investigational product.
Outcome measures
| Measure |
LY2835219 Fasted
n=23 Participants
Single oral dose of LY2835219 given with no food in one of three periods.
LY2835219: Administered orally.
|
LY2835219 High-Fat
n=24 Participants
Single oral dose of LY2835219 given with a high fat meal in one of three periods.
LY2835219: Administered orally.
|
LY2835219 High-Fat
Single oral dose of LY2835219 given with a high fat meal in one of three periods.
LY2835219: Administered orally.
|
|---|---|---|---|
|
Pharmacokinetics: Area Under the Concentration Curve (0-t Last) [AUC(0-t Last)] of LY2835219 Fasted vs. High-Fat Arms
|
4160 nanogram*hour/mL (ng*h/mL)
Geometric Coefficient of Variation 65
|
4790 nanogram*hour/mL (ng*h/mL)
Geometric Coefficient of Variation 57
|
—
|
PRIMARY outcome
Timeframe: Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each periodPopulation: All randomized participants receiving at least one dose of the investigational product.
Outcome measures
| Measure |
LY2835219 Fasted
n=23 Participants
Single oral dose of LY2835219 given with no food in one of three periods.
LY2835219: Administered orally.
|
LY2835219 High-Fat
n=24 Participants
Single oral dose of LY2835219 given with a high fat meal in one of three periods.
LY2835219: Administered orally.
|
LY2835219 High-Fat
Single oral dose of LY2835219 given with a high fat meal in one of three periods.
LY2835219: Administered orally.
|
|---|---|---|---|
|
Pharmacokinetics: Time of Maximum Observed Concentration (Tmax) of LY2835219 Fasted vs. High-Fat Arms
|
8.00 hour (h)
Interval 6.0 to 12.0
|
10.00 hour (h)
Interval 6.0 to 24.0
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each periodPopulation: All randomized participants receiving at least one dose of the investigational product.
Outcome measures
| Measure |
LY2835219 Fasted
n=22 Participants
Single oral dose of LY2835219 given with no food in one of three periods.
LY2835219: Administered orally.
|
LY2835219 High-Fat
Single oral dose of LY2835219 given with a high fat meal in one of three periods.
LY2835219: Administered orally.
|
LY2835219 High-Fat
Single oral dose of LY2835219 given with a high fat meal in one of three periods.
LY2835219: Administered orally.
|
|---|---|---|---|
|
Pharmacokinetics: Cmax of LY2835219 in Standard Meal Arm
|
141 ng/mL
Geometric Coefficient of Variation 55
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each periodPopulation: All randomized participants receiving at least one dose of the investigational product.
Outcome measures
| Measure |
LY2835219 Fasted
n=22 Participants
Single oral dose of LY2835219 given with no food in one of three periods.
LY2835219: Administered orally.
|
LY2835219 High-Fat
Single oral dose of LY2835219 given with a high fat meal in one of three periods.
LY2835219: Administered orally.
|
LY2835219 High-Fat
Single oral dose of LY2835219 given with a high fat meal in one of three periods.
LY2835219: Administered orally.
|
|---|---|---|---|
|
Pharmacokinetics: AUC(0-tlast) of LY2835219 in Standard Meal Arm
|
4610 ng*h/mL
Geometric Coefficient of Variation 65
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each periodPopulation: All randomized participants receiving at least one dose of the investigational product.
Outcome measures
| Measure |
LY2835219 Fasted
n=22 Participants
Single oral dose of LY2835219 given with no food in one of three periods.
LY2835219: Administered orally.
|
LY2835219 High-Fat
Single oral dose of LY2835219 given with a high fat meal in one of three periods.
LY2835219: Administered orally.
|
LY2835219 High-Fat
Single oral dose of LY2835219 given with a high fat meal in one of three periods.
LY2835219: Administered orally.
|
|---|---|---|---|
|
Pharmacokinetics: Tmax of LY2835219 in Standard Meal Arm
|
8.00 hour (h)
Interval 6.0 to 10.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5,1,2,3,4,6,8,10,12,24,48,72,96,120,144,168,192 hours post-LY2835219 dose in each periodPopulation: All randomized participants receiving at least one dose of the investigational product.
Area under the concentration versus time curve from time zero to time t, where t is the last time point with a measurable concentration of LSN3106726 (M20), an active metabolite of LY2835219.
Outcome measures
| Measure |
LY2835219 Fasted
n=22 Participants
Single oral dose of LY2835219 given with no food in one of three periods.
LY2835219: Administered orally.
|
LY2835219 High-Fat
n=23 Participants
Single oral dose of LY2835219 given with a high fat meal in one of three periods.
LY2835219: Administered orally.
|
LY2835219 High-Fat
n=24 Participants
Single oral dose of LY2835219 given with a high fat meal in one of three periods.
LY2835219: Administered orally.
|
|---|---|---|---|
|
Pharmacokinetics: Area Under the Concentration Curve (AUC 0-t Last) of LSN3106726 (M20)
|
3590 ng*h/mL
Geometric Coefficient of Variation 35
|
3320 ng*h/mL
Geometric Coefficient of Variation 40
|
3510 ng*h/mL
Geometric Coefficient of Variation 35
|
Adverse Events
LY2835219 Standard
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
LY2835219 Fasted
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
LY2835219 High-Fat
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LY2835219 Standard
n=23 participants at risk
Single oral dose of LY2835219 given with a standard meal in one of three study periods.
LY2835219: Administered orally.
|
LY2835219 Fasted
n=23 participants at risk
Single oral dose of LY2835219 given with no food in one of three periods.
LY2835219: Administered orally.
|
LY2835219 High-Fat
n=24 participants at risk
Single oral dose of LY2835219 given with a high fat meal in one of three periods.
LY2835219: Administered orally.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
8.7%
2/23 • Number of events 2
|
0.00%
0/23
|
12.5%
3/24 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
13.0%
3/23 • Number of events 3
|
13.0%
3/23 • Number of events 3
|
0.00%
0/24
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/23
|
8.7%
2/23 • Number of events 2
|
4.2%
1/24 • Number of events 1
|
|
Nervous system disorders
Headache
|
8.7%
2/23 • Number of events 2
|
8.7%
2/23 • Number of events 2
|
0.00%
0/24
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60