Trial Outcomes & Findings for A Study of Abemaciclib (LY2835219) in Healthy Participants With and Without Food (NCT NCT02482935)
NCT ID: NCT02482935
Last Updated: 2019-01-04
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
30 participants
Primary outcome timeframe
Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 Hours Postdose in Each Period
Results posted on
2019-01-04
Participant Flow
In this two-period crossover study, abemaciclib was administered once (fasting or fed) in each period. There were at least 16 days between doses and follow-up was completed 15 to 18 days after the last dose in Period 2.
Participant milestones
| Measure |
Abemaciclib Fasted/Fed
200 milligrams (mg) abemaciclib administered orally, once in a fasted state, then once in a fed state.
|
Abemaciclib Fed/Fasted
200 mg abemaciclib administered orally, once in a fed state, then once in a fasted state.
|
|---|---|---|
|
Period 1
STARTED
|
15
|
15
|
|
Period 1
Received Abemaciclib
|
15
|
15
|
|
Period 1
Washout
|
15
|
15
|
|
Period 1
COMPLETED
|
14
|
15
|
|
Period 1
NOT COMPLETED
|
1
|
0
|
|
Period 2
STARTED
|
14
|
15
|
|
Period 2
Received Abemaciclib
|
14
|
15
|
|
Period 2
Follow-up
|
14
|
15
|
|
Period 2
COMPLETED
|
14
|
15
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Abemaciclib Fasted/Fed
200 milligrams (mg) abemaciclib administered orally, once in a fasted state, then once in a fed state.
|
Abemaciclib Fed/Fasted
200 mg abemaciclib administered orally, once in a fed state, then once in a fasted state.
|
|---|---|---|
|
Period 1
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
A Study of Abemaciclib (LY2835219) in Healthy Participants With and Without Food
Baseline characteristics by cohort
| Measure |
Abemaciclib
n=30 Participants
200 mg abemaciclib administered once orally in each of two study periods.
|
|---|---|
|
Age, Continuous
|
49.1 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 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
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 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
|
30 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 Hours Postdose in Each PeriodPopulation: All participants who received abemaciclib and had evaluable plasma values.
Outcome measures
| Measure |
Abemaciclib Fasted
n=27 Participants
200 mg abemaciclib administered once, orally, in a fasted state.
|
Abemaciclib Fed
n=29 Participants
200 mg abemaciclib administered once, orally, in a fed state.
|
|---|---|---|
|
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-inf]) for Both Fed and Fasted Periods for Abemaciclib and Major Metabolites
Abemaciclib
|
3940 nanograms x hours/mililiters (ng·h/mL)
Geometric Coefficient of Variation 34
|
4950 nanograms x hours/mililiters (ng·h/mL)
Geometric Coefficient of Variation 42
|
|
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-inf]) for Both Fed and Fasted Periods for Abemaciclib and Major Metabolites
LSN2839567
|
1630 nanograms x hours/mililiters (ng·h/mL)
Geometric Coefficient of Variation 27
|
1910 nanograms x hours/mililiters (ng·h/mL)
Geometric Coefficient of Variation 28
|
|
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-inf]) for Both Fed and Fasted Periods for Abemaciclib and Major Metabolites
LSN3106726
|
3180 nanograms x hours/mililiters (ng·h/mL)
Geometric Coefficient of Variation 25
|
3410 nanograms x hours/mililiters (ng·h/mL)
Geometric Coefficient of Variation 28
|
PRIMARY outcome
Timeframe: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 Hours Postdose in Each PeriodPopulation: All participants who received abemaciclib and had evaluable plasma values.
Outcome measures
| Measure |
Abemaciclib Fasted
n=28 Participants
200 mg abemaciclib administered once, orally, in a fasted state.
|
Abemaciclib Fed
n=29 Participants
200 mg abemaciclib administered once, orally, in a fed state.
|
|---|---|---|
|
Pharmacokinetics: Maximum Concentration (Cmax) for Both Fed and Fasted Periods for Abemaciclib and Major Metabolites
LSN2839567
|
33.4 ng/mL
Geometric Coefficient of Variation 36
|
41.4 ng/mL
Geometric Coefficient of Variation 29
|
|
Pharmacokinetics: Maximum Concentration (Cmax) for Both Fed and Fasted Periods for Abemaciclib and Major Metabolites
LSN3106726
|
55.7 ng/mL
Geometric Coefficient of Variation 31
|
61.0 ng/mL
Geometric Coefficient of Variation 29
|
|
Pharmacokinetics: Maximum Concentration (Cmax) for Both Fed and Fasted Periods for Abemaciclib and Major Metabolites
Abemaciclib
|
116 ng/mL
Geometric Coefficient of Variation 36
|
159 ng/mL
Geometric Coefficient of Variation 38
|
SECONDARY outcome
Timeframe: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, 96, 120, 144, 168, and 192 Hours Postdose in Each PeriodPopulation: All participants who received abemaciclib and had evaluable plasma values.
Outcome measures
| Measure |
Abemaciclib Fasted
n=28 Participants
200 mg abemaciclib administered once, orally, in a fasted state.
|
Abemaciclib Fed
n=29 Participants
200 mg abemaciclib administered once, orally, in a fed state.
|
|---|---|---|
|
Pharmacokinetics: Time to Maximum Concentration (Tmax) for Both Fed and Fasted Periods for Abemaciclib and Major Metabolites
Abemaciclib
|
8.00 hours
Interval 6.0 to 12.0
|
8.00 hours
Interval 6.0 to 12.0
|
|
Pharmacokinetics: Time to Maximum Concentration (Tmax) for Both Fed and Fasted Periods for Abemaciclib and Major Metabolites
LSN2839567
|
6.00 hours
Interval 3.0 to 12.0
|
6.00 hours
Interval 4.0 to 12.0
|
|
Pharmacokinetics: Time to Maximum Concentration (Tmax) for Both Fed and Fasted Periods for Abemaciclib and Major Metabolites
LSN3106726
|
8.02 hours
Interval 6.0 to 24.02
|
10.00 hours
Interval 6.0 to 24.03
|
Adverse Events
Abemaciclib Fasted
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Abemaciclib Fed
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Abemaciclib Fasted
n=30 participants at risk
200 mg abemaciclib administered once, orally, in a fasted state.
|
Abemaciclib Fed
n=29 participants at risk
200 mg abemaciclib administered once, orally, in a fed state.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
10.0%
3/30 • Number of events 3
All participants who received abemaciclib.
|
0.00%
0/29
All participants who received abemaciclib.
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
2/30 • Number of events 2
All participants who received abemaciclib.
|
0.00%
0/29
All participants who received abemaciclib.
|
|
Nervous system disorders
Headache
|
3.3%
1/30 • Number of events 1
All participants who received abemaciclib.
|
6.9%
2/29 • Number of events 2
All participants who received abemaciclib.
|
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