Trial Outcomes & Findings for A Study of Evacetrapib (LY2484595) in Participants With Severe Renal Impairment and in Healthy Participants (NCT NCT01825889)
NCT ID: NCT01825889
Last Updated: 2018-10-09
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
20 participants
Primary outcome timeframe
Predose and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, 264, 312, and 336 hours postdose
Results posted on
2018-10-09
Participant Flow
Participant milestones
| Measure |
Evacetrapib (Participants With Renal Impairment)
Single oral dose of 130 milligrams (mg) evacetrapib on Day 1 to participants with severe renal impairment.
|
Evacetrapib (Healthy Participants)
Single oral dose of 130 mg evacetrapib on Day 1 to participants with normal renal function.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
Received One Dose of Study Drug
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Evacetrapib (LY2484595) in Participants With Severe Renal Impairment and in Healthy Participants
Baseline characteristics by cohort
| Measure |
Evacetrapib (Participants With Renal Impairment)
n=10 Participants
Single oral dose of 130 mg evacetrapib on Day 1 to participants with severe renal impairment.
|
Evacetrapib (Healthy Participants)
n=10 Participants
Single oral dose of 130 mg evacetrapib on Day 1 to participants with normal renal function.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.2 years
STANDARD_DEVIATION 9.6 • n=99 Participants
|
61.5 years
STANDARD_DEVIATION 8.0 • n=107 Participants
|
63.4 years
STANDARD_DEVIATION 8.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Predose and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, 264, 312, and 336 hours postdosePopulation: All participants who received evacetrapib and had evaluable AUC(0-Tlast) data.
Outcome measures
| Measure |
Evacetrapib (Participants With Renal Impairment)
n=10 Participants
Single oral dose of 130 mg evacetrapib on Day 1 to participants with severe renal impairment.
|
Evacetrapib (Healthy Participants)
n=10 Participants
Single oral dose of 130 mg evacetrapib on Day 1 to participants with normal renal function.
|
|---|---|---|
|
Pharmacokinetics (PK): Area Under The Concentration Versus Time Curve From Time Zero To Time Tlast, Where Tlast is the Last Time Point With a Measurable Concentration (AUC[0-Tlast]) of Evacetrapib
|
15200 nanograms*hours/milliliter (ng*h/mL)
Geometric Coefficient of Variation 49
|
16000 nanograms*hours/milliliter (ng*h/mL)
Geometric Coefficient of Variation 37
|
PRIMARY outcome
Timeframe: Predose and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, 264, 312, and 336 hours postdosePopulation: All participants who received evacetrapib and had evaluable AUC(0-∞) data.
Outcome measures
| Measure |
Evacetrapib (Participants With Renal Impairment)
n=10 Participants
Single oral dose of 130 mg evacetrapib on Day 1 to participants with severe renal impairment.
|
Evacetrapib (Healthy Participants)
n=10 Participants
Single oral dose of 130 mg evacetrapib on Day 1 to participants with normal renal function.
|
|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time Zero to Infinity (AUC[0-∞]) of Evacetrapib
|
15500 ng*h/mL
Geometric Coefficient of Variation 50
|
16300 ng*h/mL
Geometric Coefficient of Variation 39
|
SECONDARY outcome
Timeframe: Predose and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, 264, 312, and 336 hours postdosePopulation: All participants who received evacetrapib and had evaluable Cmax data.
Outcome measures
| Measure |
Evacetrapib (Participants With Renal Impairment)
n=10 Participants
Single oral dose of 130 mg evacetrapib on Day 1 to participants with severe renal impairment.
|
Evacetrapib (Healthy Participants)
n=10 Participants
Single oral dose of 130 mg evacetrapib on Day 1 to participants with normal renal function.
|
|---|---|---|
|
Pharmacokinetics (PK): Observed Maximum Concentration (Cmax) of Evacetrapib
|
969 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 43
|
1140 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 44
|
Adverse Events
Evacetrapib (Participants With Renal Impairment)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Evacetrapib (Healthy Participants)
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 |
Evacetrapib (Participants With Renal Impairment)
n=10 participants at risk
Single oral dose of 130 mg evacetrapib on Day 1 to participants with severe renal impairment.
|
Evacetrapib (Healthy Participants)
n=10 participants at risk
Single oral dose of 130 mg evacetrapib on Day 1 to participants with normal renal function.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Vessel puncture site swelling
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/10
|
10.0%
1/10 • Number of events 1
|
|
Metabolism and nutrition disorders
Gout
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
|
Nervous system disorders
Dizziness
|
10.0%
1/10 • Number of events 1
|
0.00%
0/10
|
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