Trial Outcomes & Findings for Study of Food on Evacetrapib (LY2484595) in Healthy Participants (NCT NCT01810432)
NCT ID: NCT01810432
Last Updated: 2018-10-12
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
40 participants
Primary outcome timeframe
Day 10 Periods 1 and 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dose
Results posted on
2018-10-12
Participant Flow
Participant milestones
| Measure |
Sequence 1 (Fast/Fed)
Participants received a 130 milligram (mg) oral tablet of evacetrapib once daily (QD) for 10 days (Period 1) in a fasted state. Following a 14-day washout period participants received a 130 mg oral tablet of evacetrapib QD for 10 days (Period 2) following a high-fat breakfast.
|
Sequence 2 (Fed/Fasted)
Participants received a 130 mg oral tablet of evacetrapib QD for 10 days (Period 1) following a high-fat breakfast. Following a 14-day washout period participants received a 130 mg oral tablet of evacetrapib QD for 10 days (Period 2) in a fasted state.
|
|---|---|---|
|
Period 1
STARTED
|
20
|
20
|
|
Period 1
Received at Least 1 Dose of Study Drug
|
20
|
20
|
|
Period 1
COMPLETED
|
20
|
20
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
Washout
STARTED
|
20
|
20
|
|
Washout
COMPLETED
|
19
|
19
|
|
Washout
NOT COMPLETED
|
1
|
1
|
|
Period 2
STARTED
|
19
|
19
|
|
Period 2
Received at Least 1 Dose of Study Drug
|
19
|
19
|
|
Period 2
COMPLETED
|
15
|
17
|
|
Period 2
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
Sequence 1 (Fast/Fed)
Participants received a 130 milligram (mg) oral tablet of evacetrapib once daily (QD) for 10 days (Period 1) in a fasted state. Following a 14-day washout period participants received a 130 mg oral tablet of evacetrapib QD for 10 days (Period 2) following a high-fat breakfast.
|
Sequence 2 (Fed/Fasted)
Participants received a 130 mg oral tablet of evacetrapib QD for 10 days (Period 1) following a high-fat breakfast. Following a 14-day washout period participants received a 130 mg oral tablet of evacetrapib QD for 10 days (Period 2) in a fasted state.
|
|---|---|---|
|
Washout
Protocol Violation
|
0
|
1
|
|
Washout
Adverse Event
|
1
|
0
|
|
Period 2
Withdrawal by Subject
|
2
|
1
|
|
Period 2
Physician Decision
|
1
|
0
|
|
Period 2
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
Study of Food on Evacetrapib (LY2484595) in Healthy Participants
Baseline characteristics by cohort
| Measure |
Evacetrapib
n=40 Participants
Sequence 1-participants received a 130 mg oral tablet of evacetrapib QD for 10 days (Period 1) in a fasted state. Following a 14-day washout period, participants received a 130 mg oral tablet of evacetrapib QD for 10 days (Period 2) following a high-fat breakfast.
Sequence 2-participants received a 130 mg oral tablet of evacetrapib QD for 10 days (Period 1) following a high-fat breakfast. Following a 14-day washout period participants received a 130 mg oral tablet of evacetrapib QD for 10 days (Period 2) in a fasted state.
|
|---|---|
|
Age, Continuous
|
41.5 years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 10 Periods 1 and 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dosePopulation: All participants with evaluable Cmax data.
Outcome measures
| Measure |
Evacetrapib (Fasted)
n=39 Participants
Participants received a 130 mg oral tablet of evacetrapib QD in a fasted state for 10 days.
|
Evacetrapib (Fed)
n=37 Participants
Participants received a 130 mg oral tablet of evacetrapib QD following a high-fat breakfast for 10 days.
|
|---|---|---|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Evacetrapib
|
1140 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 73
|
1720 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 22
|
PRIMARY outcome
Timeframe: Day 10 Periods 1 and 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dosePopulation: All participants with evaluable AUCτ data.
Outcome measures
| Measure |
Evacetrapib (Fasted)
n=39 Participants
Participants received a 130 mg oral tablet of evacetrapib QD in a fasted state for 10 days.
|
Evacetrapib (Fed)
n=36 Participants
Participants received a 130 mg oral tablet of evacetrapib QD following a high-fat breakfast for 10 days.
|
|---|---|---|
|
PK: Area Under Concentration Versus Time Curve Over the 24-hour Dosing Interval (AUCτ) of Evacetrapib
|
9930 nanograms*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 49
|
14400 nanograms*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 19
|
PRIMARY outcome
Timeframe: Day 10 Periods 1 and 2: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, and 24 hours post-dosePopulation: All participants with evaluable tmax data.
Outcome measures
| Measure |
Evacetrapib (Fasted)
n=39 Participants
Participants received a 130 mg oral tablet of evacetrapib QD in a fasted state for 10 days.
|
Evacetrapib (Fed)
n=37 Participants
Participants received a 130 mg oral tablet of evacetrapib QD following a high-fat breakfast for 10 days.
|
|---|---|---|
|
PK: Time of Maximum Observed Drug Concentration (Tmax) of Evacetrapib
|
3.00 hours (h)
Interval 1.0 to 6.03
|
3.00 hours (h)
Interval 1.0 to 6.0
|
Adverse Events
Evacetrapib (Fasted)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Evacetrapib (Fed)
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 |
Evacetrapib (Fasted)
n=39 participants at risk
Participants received 130-mg oral tablet fo evacetrapib QD in a fasted state for 10 days.
|
Evacetrapib (Fed)
n=39 participants at risk
Participants received 130-mg oral tablet of evacetrapib QD following a high-fat breakfast for 10 days.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
5.1%
2/39 • Number of events 2
The total number of participants at risk in the Fasted and Fed groups is the number of participants who started Period 1 and Period 2.
|
2.6%
1/39 • Number of events 1
The total number of participants at risk in the Fasted and Fed groups is the number of participants who started Period 1 and Period 2.
|
|
Gastrointestinal disorders
Diarrhoea
|
10.3%
4/39 • Number of events 4
The total number of participants at risk in the Fasted and Fed groups is the number of participants who started Period 1 and Period 2.
|
0.00%
0/39
The total number of participants at risk in the Fasted and Fed groups is the number of participants who started Period 1 and Period 2.
|
|
Nervous system disorders
Headache
|
5.1%
2/39 • Number of events 2
The total number of participants at risk in the Fasted and Fed groups is the number of participants who started Period 1 and Period 2.
|
7.7%
3/39 • Number of events 3
The total number of participants at risk in the Fasted and Fed groups is the number of participants who started Period 1 and Period 2.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.1%
2/39 • Number of events 2
The total number of participants at risk in the Fasted and Fed groups is the number of participants who started Period 1 and Period 2.
|
0.00%
0/39
The total number of participants at risk in the Fasted and Fed groups is the number of participants who started Period 1 and Period 2.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
5.1%
2/39 • Number of events 2
The total number of participants at risk in the Fasted and Fed groups is the number of participants who started Period 1 and Period 2.
|
0.00%
0/39
The total number of participants at risk in the Fasted and Fed groups is the number of participants who started Period 1 and Period 2.
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee Investigators agreed to delay independently publishing or disclosing data, findings or conclusions from the study except as part of a multi-center publication. Upon study publication or if the draft publication is not produced within approximately 6 months of the final report of the study results, investigators may independently publish, subject to confidential information review/redaction by sponsor. The sponsor may request publication delay up to 90 days to seek patent protection.
- Publication restrictions are in place
Restriction type: OTHER