A Study of Evacetrapib and Rifampin in Healthy Participants

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01908582
• Collaborator: (none)
• Enrollment: 26
• Location: 1
• Arms: 2
• Duration (Months): 2
• Patients Per Site Per Month: 12.8

Study Details

Study Description

Brief Summary

The main purpose of this study is to determine how much evacetrapib gets into the blood stream and how long it takes the body to get rid of it when given with rifampin. The safety and tolerability of the two drugs, given together, will also be evaluated. The study will also look at blood cholesterol levels and levels of a hormone called cortisol before and after taking rifampin. Information about any side effects that may occur will also be collected.

For each participant, this study will include 2 periods in fixed order. The study will last approximately 29 days.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: Evacetrapib; Drug: Rifampin	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 26 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Effect of Rifampin on the Pharmacokinetics of Evacetrapib in Healthy Subjects
• Study Start Date: Jul 1, 2013
• Actual Primary Completion Date: Sep 1, 2013
• Actual Study Completion Date: Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Evacetrapib Period 1: 130 milligram (mg) evacetrapib administered orally, once on Day 1	Drug: Evacetrapib; Administered orally; Other Names: LY2484595
Experimental: Evacetrapib + Rifampin Period 2: Rifampin: 600 mg administered orally, once daily (QD) for 14 days (Days 9 to 22) Evacetrapib: 130 mg administered orally once on Day 16	Drug: Evacetrapib; Administered orally; Other Names: LY2484595 ; Drug: Rifampin; Administered orally

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of Evacetrapib [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]

2. Pharmacokinetics (PK): Time of Maximum Observed Drug Concentration (Tmax) of Evacetrapib [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]

3. Pharmacokinetics, Area Under the Plasma Concentration-Time Curve From Time 0 Hour (h) to Infinity (AUC0-∞) of Evacetrapib [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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Overtly healthy males and females (of non child-bearing potential)

• Have a body mass index of 18 to 32 kilograms per square meter (kg/m^2), inclusive, at screening

Exclusion Criteria:

• Have known allergies to evacetrapib, rifampin, related compounds or any components of either formulation, or history of significant allergic disease as determined by the investigator

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	Madison	Wisconsin	United States	53704

Sponsors and Collaborators

• Eli Lilly and Company

Investigators

• Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT01908582
• Other Study ID Numbers: 14636; I1V-MC-EIAZ
• First Posted: Jul 25, 2013
• Last Update Posted: Oct 3, 2018
• Last Verified: Feb 1, 2018

• Additional relevant MeSH terms: Rifampin; Evacetrapib

Study Results

Participant Flow

Arm/Group Title	All Participants
Arm/Group Description	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 Title: Period 1
STARTED	26
Received at Least One Dose of Study Drug	26
COMPLETED	26
NOT COMPLETED	0
Period Title: Period 1
STARTED	26
COMPLETED	24
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	All Participants
Arm/Group Description	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
Overall Participants	26
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	41.0 (11.4)
Sex: Female, Male (Count of Participants)
Female	6 23.1%
Male	20 76.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 3.8%
Not Hispanic or Latino	25 96.2%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	11 42.3%
White	15 57.7%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (Count of Participants)
United States	26 100%

Outcome Measures

1. Primary Outcome

Title	Pharmacokinetics (PK): Maximum Concentration (Cmax) of Evacetrapib
Time Frame	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Evacetrapib	Evacetrapib + Rifampin
Arm/Group Description	Period 1: Evacetrapib 130 mg administered orally as a single dose on Day 1	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
Measure Participants	25	25
Geometric Mean (Geometric Coefficient of Variation) [nanograms per milliliter (ng/mL)]	599 (64)	269 (55)

2. Primary Outcome

Title	Pharmacokinetics (PK): Time of Maximum Observed Drug Concentration (Tmax) of Evacetrapib
Time Frame	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Evacetrapib	Evacetrapib + Rifampin
Arm/Group Description	Period 1: Evacetrapib 130 mg administered orally as a single dose on Day 1	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
Measure Participants	25	25
Median (Full Range) [hours]	2.00	2.00

3. Primary Outcome

Title	Pharmacokinetics, Area Under the Plasma Concentration-Time Curve From Time 0 Hour (h) to Infinity (AUC0-∞) of Evacetrapib
Time Frame	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Evacetrapib	Evacetrapib + Rifampin
Arm/Group Description	Period 1: Evacetrapib 130 mg administered orally as a single dose on Day 1	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
Measure Participants	25	24
Geometric Mean (Geometric Coefficient of Variation) [nanograms * hours per milliliter]	9810 (47)	2070 (42)

Adverse Events

Arm/Group Title	Evacetrapib		Rifampin		Evacetrapib + Rifampin
Arm/Group Description	Period 1: Evacetrapib 130 mg administered orally as a single dose on Day 1.		Period 2: 600 mg rifampin administered orally as a single dose QD on Days 9 through 15.		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
All Cause Mortality
	Evacetrapib		Rifampin		Evacetrapib + Rifampin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Evacetrapib		Rifampin		Evacetrapib + Rifampin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/26 (0%)		0/26 (0%)
Other (Not Including Serious) Adverse Events
	Evacetrapib		Rifampin		Evacetrapib + Rifampin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/26 (11.5%)		26/26 (100%)		5/26 (19.2%)
General disorders
Vessel puncture site pain	1/26 (3.8%)	2	1/26 (3.8%)	1	2/26 (7.7%)	2
Nervous system disorders
Headache	2/26 (7.7%)	2	2/26 (7.7%)	2	3/26 (11.5%)	3
Renal and urinary disorders
Chromaturia	0/26 (0%)	0	26/26 (100%)	26	0/26 (0%)	0
Skin and subcutaneous tissue disorders
Rash	0/26 (0%)	0	1/26 (3.8%)	1	2/26 (7.7%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.