Trial Outcomes & Findings for A Study of Evacetrapib and Rifampin in Healthy Participants (NCT NCT01908582)

NCT ID: NCT01908582

Last Updated: 2018-10-03

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 26 participants
• Primary outcome timeframe: Day 1 and Day 16, predose of evacetrapib and 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	All Participants Period 1: Evacetrapib 130 milligrams (mg) administered orally as a single dose on Day 1 Period 2: Rifampin 600 mg administered orally once daily (QD) of Days 9 to 22 Evacetrapib 130 mg administered orally as a single dose on Day 16
Period 1 STARTED	26
Period 1 Received at Least One Dose of Study Drug	26
Period 1 COMPLETED	26
Period 1 NOT COMPLETED	0
Period 2 STARTED	26
Period 2 COMPLETED	24
Period 2 NOT COMPLETED	2

Reasons for withdrawal

Measure	All Participants Period 1: Evacetrapib 130 milligrams (mg) administered orally as a single dose on Day 1 Period 2: Rifampin 600 mg administered orally once daily (QD) of Days 9 to 22 Evacetrapib 130 mg administered orally as a single dose on Day 16
Period 2 Physician Decision	1
Period 2 Withdrawal by Subject	1

Baseline Characteristics

A Study of Evacetrapib and Rifampin in Healthy Participants

Baseline characteristics by cohort

Measure	All Participants n=26 Participants Period 1: Evacetrapib 130 mg administered orally as a single dose on Day 1 Period 2: Rifampin 600 mg administered orally QD of Days 9 to 22 Evacetrapib 130 mg administered orally as a single dose on Day 16
Age, Continuous	41.0 years STANDARD_DEVIATION 11.4 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	25 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	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	11 Participants n=5 Participants
Race (NIH/OMB) White	15 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	26 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 and Day 16, predose of evacetrapib and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose

Population: All participants who received at least 1 dose of rifampin or evacetrapib and had evaluable evacetrapib concentration data.

Outcome measures

Measure	Evacetrapib n=25 Participants Period 1: Evacetrapib 130 mg administered orally as a single dose on Day 1	Evacetrapib + Rifampin n=25 Participants Period 2: Rifampin 600 mg administered orally, QD on Days 9 to 22 (14 consecutive days) Evacetrapib 130 mg administered orally as a single dose on Day 16
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Evacetrapib	599 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 64	269 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 55

PRIMARY outcome

Timeframe: Day 1 and Day 16, predose of evacetrapib and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose

Population: All participants who received at least 1 dose of rifampin or evacetrapib and had evaluable evacetrapib concentration data.

Outcome measures

Measure	Evacetrapib n=25 Participants Period 1: Evacetrapib 130 mg administered orally as a single dose on Day 1	Evacetrapib + Rifampin n=25 Participants Period 2: Rifampin 600 mg administered orally, QD on Days 9 to 22 (14 consecutive days) Evacetrapib 130 mg administered orally as a single dose on Day 16
Pharmacokinetics (PK): Time of Maximum Observed Drug Concentration (Tmax) of Evacetrapib	2.00 hours Interval 2.0 to 4.0	2.00 hours Interval 1.0 to 6.0

PRIMARY outcome

Timeframe: Day 1 and Day 16, predose of evacetrapib and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120, 144, and 168 hours postdose

Population: All participants who received at least 1 dose of evacetrapib and have evaluable evacetrapib concentration data.

Outcome measures

Measure	Evacetrapib n=25 Participants Period 1: Evacetrapib 130 mg administered orally as a single dose on Day 1	Evacetrapib + Rifampin n=24 Participants Period 2: Rifampin 600 mg administered orally, QD on Days 9 to 22 (14 consecutive days) Evacetrapib 130 mg administered orally as a single dose on Day 16
Pharmacokinetics, Area Under the Plasma Concentration-Time Curve From Time 0 Hour (h) to Infinity (AUC0-∞) of Evacetrapib	9810 nanograms * hours per milliliter Geometric Coefficient of Variation 47	2070 nanograms * hours per milliliter Geometric Coefficient of Variation 42

Adverse Events

Evacetrapib

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Rifampin

Serious events: 0 serious events

Other events: 26 other events

Deaths: 0 deaths

Evacetrapib + Rifampin

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Evacetrapib n=26 participants at risk Period 1: Evacetrapib 130 mg administered orally as a single dose on Day 1.	Rifampin n=26 participants at risk Period 2: 600 mg rifampin administered orally as a single dose QD on Days 9 through 15.	Evacetrapib + Rifampin n=26 participants at risk Period 2: Rifampin 600 mg administered orally, QD on Days 16 to 22 Evacetrapib 130 mg administered orally as a single dose on Day 16
General disorders Vessel puncture site pain	3.8% 1/26 • Number of events 2	3.8% 1/26 • Number of events 1	7.7% 2/26 • Number of events 2
Nervous system disorders Headache	7.7% 2/26 • Number of events 2	7.7% 2/26 • Number of events 2	11.5% 3/26 • Number of events 3
Renal and urinary disorders Chromaturia	0.00% 0/26	100.0% 26/26 • Number of events 26	0.00% 0/26
Skin and subcutaneous tissue disorders Rash	0.00% 0/26	3.8% 1/26 • Number of events 1	7.7% 2/26 • Number of events 2

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