Trial Outcomes & Findings for A Study of Evacetrapib and Digoxin in Healthy Participants (NCT NCT01897493)
NCT ID: NCT01897493
Last Updated: 2018-10-09
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
Periods 1 and 2: digoxin predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after administration of digoxin
Results posted on
2018-10-09
Participant Flow
Participant milestones
| Measure |
Evacetrapib+Digoxin
Period 1 (Day 1 through Day 6 predose): Participants received a single oral dose of 0.5 milligrams (mg) digoxin on Day 1 Period 2 (Day 6 postdose through Day 20): Participants received an oral dose of 130 mg evacetrapib once daily (QD) on Days 6 through 19 with single oral dose of 0.5 mg digoxin administered on Day 15
|
|---|---|
|
Period 1 (Day 1 Through Day 6 Predose)
STARTED
|
16
|
|
Period 1 (Day 1 Through Day 6 Predose)
Received at Least 1 Dose of Study Drug
|
16
|
|
Period 1 (Day 1 Through Day 6 Predose)
COMPLETED
|
15
|
|
Period 1 (Day 1 Through Day 6 Predose)
NOT COMPLETED
|
1
|
|
Period 2 (Day 6 Postdose Through Day 20)
STARTED
|
15
|
|
Period 2 (Day 6 Postdose Through Day 20)
Received at Least 1 Dose of Study Drug
|
15
|
|
Period 2 (Day 6 Postdose Through Day 20)
COMPLETED
|
15
|
|
Period 2 (Day 6 Postdose Through Day 20)
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
Evacetrapib+Digoxin
Period 1 (Day 1 through Day 6 predose): Participants received a single oral dose of 0.5 milligrams (mg) digoxin on Day 1 Period 2 (Day 6 postdose through Day 20): Participants received an oral dose of 130 mg evacetrapib once daily (QD) on Days 6 through 19 with single oral dose of 0.5 mg digoxin administered on Day 15
|
|---|---|
|
Period 1 (Day 1 Through Day 6 Predose)
Withdrawal by Subject
|
1
|
Baseline Characteristics
A Study of Evacetrapib and Digoxin in Healthy Participants
Baseline characteristics by cohort
| Measure |
Evacetrapib+Digoxin
n=16 Participants
Period 1 (Day 1 through Day 6 Predose): Participants received a single oral dose of 0.5 mg digoxin on Day 1 Period 2 (Day 6 Post-Dose through Day 20): Participants received an oral dose of 130 mg evacetrapib QD on Days 6 through 19 with a single oral dose of 0.5 mg digoxin administered on Day 15
|
|---|---|
|
Age, Continuous
|
38.6 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 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
|
6 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
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Periods 1 and 2: digoxin predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after administration of digoxinPopulation: All enrolled participants who received digoxin in Periods 1 and 2 and had evaluable Cmax data.
Outcome measures
| Measure |
Period 1-Digoxin
n=16 Participants
Digoxin: Participants received 0.5 mg digoxin administered orally QD on Day 1
|
Period 2-Evacetrapib + Digoxin
n=15 Participants
Evacetrapib+Digoxin: Participants received 130 mg evacetrapib administered orally, QD for 14 days (Days 6 through 19) with a single oral dose of 0.5 mg digoxin coadministered on Day 15
|
|---|---|---|
|
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Digoxin
|
1.75 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 28
|
2.15 nanograms/milliliter (ng/mL)
Geometric Coefficient of Variation 32
|
PRIMARY outcome
Timeframe: Periods 1 and 2: digoxin predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after administration of digoxinPopulation: All enrolled participants who received digoxin in Periods 1 and 2 and had evaluable AUC0-∞ data.
Outcome measures
| Measure |
Period 1-Digoxin
n=16 Participants
Digoxin: Participants received 0.5 mg digoxin administered orally QD on Day 1
|
Period 2-Evacetrapib + Digoxin
n=15 Participants
Evacetrapib+Digoxin: Participants received 130 mg evacetrapib administered orally, QD for 14 days (Days 6 through 19) with a single oral dose of 0.5 mg digoxin coadministered on Day 15
|
|---|---|---|
|
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-∞) of Digoxin
|
31.3 nanograms*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 18
|
33.5 nanograms*hour/milliliter (ng*h/mL)
Geometric Coefficient of Variation 26
|
PRIMARY outcome
Timeframe: Periods 1 and 2: digoxin predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after administration of digoxinPopulation: All enrolled participants who received digoxin in Periods 1 and 2 and had evaluable tmax data.
Outcome measures
| Measure |
Period 1-Digoxin
n=16 Participants
Digoxin: Participants received 0.5 mg digoxin administered orally QD on Day 1
|
Period 2-Evacetrapib + Digoxin
n=15 Participants
Evacetrapib+Digoxin: Participants received 130 mg evacetrapib administered orally, QD for 14 days (Days 6 through 19) with a single oral dose of 0.5 mg digoxin coadministered on Day 15
|
|---|---|---|
|
PK: Time of Maximum Observed Drug Concentration (Tmax) of Digoxin
|
2.00 hours
Interval 1.0 to 2.0
|
2.00 hours
Interval 1.0 to 2.0
|
SECONDARY outcome
Timeframe: Periods 1 and 2: digoxin predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, and 96 hours after administration of digoxinPopulation: All enrolled participants who received digoxin in Periods 1 and 2 and had evaluable CLr data.
CLr was defined as the volume of serum cleared of digoxin per unit of time after a single dose of digoxin.
Outcome measures
| Measure |
Period 1-Digoxin
n=16 Participants
Digoxin: Participants received 0.5 mg digoxin administered orally QD on Day 1
|
Period 2-Evacetrapib + Digoxin
n=15 Participants
Evacetrapib+Digoxin: Participants received 130 mg evacetrapib administered orally, QD for 14 days (Days 6 through 19) with a single oral dose of 0.5 mg digoxin coadministered on Day 15
|
|---|---|---|
|
Renal Clearance (CLr) of Digoxin
|
9.43 liters/hour (L/h)
Geometric Coefficient of Variation 14
|
8.10 liters/hour (L/h)
Geometric Coefficient of Variation 18
|
Adverse Events
Digoxin
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Evacetrapib
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Evacetrapib + Digoxin
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Digoxin
n=16 participants at risk
Digoxin: Participants received a single dose of 0.5 mg digoxin administered orally on Day 1. Adverse events (AEs) are reported through predose on Day 6
|
Evacetrapib
n=15 participants at risk
Evacetrapib: Participants received 130 mg evacetrapib administered orally, alone, QD for Days 6 up to 15. AEs are reported from post-dose on Day 6 through predose of Digoxin on Day 15.
|
Evacetrapib + Digoxin
n=15 participants at risk
Evacetrapib+Digoxin: Participants received 130 mg evacetrapib administered orally, QD for 14 days (Days 6 to 19) with a single oral dose of 0.5 mg digoxin coadministered on Day 15. AEs are reported from post-dose on Day 15 up to Day 33.
|
|---|---|---|---|
|
Infections and infestations
Rhinitis
|
6.2%
1/16 • Number of events 1
|
0.00%
0/15
|
0.00%
0/15
|
|
Nervous system disorders
Headache
|
0.00%
0/16
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/16
|
0.00%
0/15
|
6.7%
1/15 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/16
|
6.7%
1/15 • Number of events 1
|
0.00%
0/15
|
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