Trial Outcomes & Findings for A Study to Evaluate the Effect of Increased Stomach pH on Evacetrapib in Healthy Participants (NCT NCT02365558)
NCT ID: NCT02365558
Last Updated: 2018-10-03
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
34 participants
Primary outcome timeframe
Day 1 and Day 14 at 0, 1, 2, 3, 4, 6, 8,12, 24, 36, 48, 72, 96, 120, 144 and 168 Hours Postdose
Results posted on
2018-10-03
Participant Flow
Participant milestones
| Measure |
Evacetrapib
Evacetrapib 130 milligram (mg) administered as a single oral dose on Day 1.
|
Evacetrapib + Omeprazole
Omeprazole 40 mg administered once daily (QD) orally on Day 8 through 20. Evacetrapib 130mg coadministered as a single oral dose on Day 14.
|
|---|---|---|
|
Period 1 (Day 1 Through Day 7)
STARTED
|
34
|
0
|
|
Period 1 (Day 1 Through Day 7)
Received at Least One Dose of Study Drug
|
34
|
0
|
|
Period 1 (Day 1 Through Day 7)
COMPLETED
|
33
|
0
|
|
Period 1 (Day 1 Through Day 7)
NOT COMPLETED
|
1
|
0
|
|
Period 2 (Day 8 Through Day 20)
STARTED
|
0
|
33
|
|
Period 2 (Day 8 Through Day 20)
COMPLETED
|
0
|
32
|
|
Period 2 (Day 8 Through Day 20)
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Evacetrapib
Evacetrapib 130 milligram (mg) administered as a single oral dose on Day 1.
|
Evacetrapib + Omeprazole
Omeprazole 40 mg administered once daily (QD) orally on Day 8 through 20. Evacetrapib 130mg coadministered as a single oral dose on Day 14.
|
|---|---|---|
|
Period 1 (Day 1 Through Day 7)
Adverse Event
|
1
|
0
|
|
Period 2 (Day 8 Through Day 20)
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
A Study to Evaluate the Effect of Increased Stomach pH on Evacetrapib in Healthy Participants
Baseline characteristics by cohort
| Measure |
Overall Study
n=34 Participants
Single oral dose of 130 mg evacetrapib on Day 1 and oral doses of 40 mg omeprazole QD on Days 8 through 20, with a single oral dose of 130 mg evacetrapib coadministered on Day 14
|
|---|---|
|
Age, Continuous
|
40.9 Years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 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
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 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
|
34 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 and Day 14 at 0, 1, 2, 3, 4, 6, 8,12, 24, 36, 48, 72, 96, 120, 144 and 168 Hours PostdosePopulation: All participants who received at least one dose of study drug.
Outcome measures
| Measure |
Evacetrapib
n=34 Participants
Single oral dose of Evacetrapib administered on Day 1 of Period 1
|
Evacetrapib + Omeprazole
n=33 Participants
In Period 2, Participants will receive 40 mg oral dose of Omeprazole QD on Days 8 through 20.
Evacetrapib will be coadministered once, orally on Day 14.
|
|---|---|---|
|
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Evacetrapib
|
748 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 79
|
959 nanograms per milliliter (ng/mL)
Geometric Coefficient of Variation 88
|
PRIMARY outcome
Timeframe: Day 1 and Day 14 at 0, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144 and 168 Hours PostdosePopulation: All participants who received at least one dose of study drug.
Outcome measures
| Measure |
Evacetrapib
n=34 Participants
Single oral dose of Evacetrapib administered on Day 1 of Period 1
|
Evacetrapib + Omeprazole
n=33 Participants
In Period 2, Participants will receive 40 mg oral dose of Omeprazole QD on Days 8 through 20.
Evacetrapib will be coadministered once, orally on Day 14.
|
|---|---|---|
|
Pharmacokinetics (PK): Time of Maximum Observed Concentration (Tmax) of Evacetrapib
|
3.00 Hours
Interval 2.0 to 6.0
|
3.00 Hours
Interval 1.0 to 6.0
|
PRIMARY outcome
Timeframe: Day 1 and Day 14 at 0, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144 and 168 Hours PostdosePopulation: All participants who received at least one dose of study drug.
Outcome measures
| Measure |
Evacetrapib
n=34 Participants
Single oral dose of Evacetrapib administered on Day 1 of Period 1
|
Evacetrapib + Omeprazole
n=33 Participants
In Period 2, Participants will receive 40 mg oral dose of Omeprazole QD on Days 8 through 20.
Evacetrapib will be coadministered once, orally on Day 14.
|
|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞])
|
12400 nanogram*hour per milliliter (ng·h/mL)
Geometric Coefficient of Variation 52
|
14100 nanogram*hour per milliliter (ng·h/mL)
Geometric Coefficient of Variation 66
|
Adverse Events
Evacetrapib
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Evacetrapib + Omeprazole
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Evacetrapib + Omeprazole Follow-up
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Evacetrapib
n=34 participants at risk
Single oral dose of Evacetrapib administered alone on Day 1 of Period 1.
Evacetrapib: Administered orally
|
Evacetrapib + Omeprazole
n=33 participants at risk
In Period 2, participants will receive 40 mg oral dose of Omeprazole once daily (QD) on Days 8 through 20.
Evacetrapib will be coadministered once, orally on Day 14.
Evacetrapib: Administered orally
Omeprazole: Administered orally
|
Evacetrapib + Omeprazole Follow-up
n=33 participants at risk
Evacetrapib + Omeprazole Follow-up will occur at least 14 days after last dose of Evacetrapib on Day 14.
|
|---|---|---|---|
|
General disorders
Vessel puncture site reaction
|
2.9%
1/34 • Number of events 1
|
0.00%
0/33
|
6.1%
2/33 • Number of events 2
|
|
Nervous system disorders
Headache
|
11.8%
4/34 • Number of events 5
|
6.1%
2/33 • Number of events 3
|
3.0%
1/33 • Number of events 1
|
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