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A Study of Evacetrapib and Rifampin in Healthy Participants

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Lilly

Status and phase

Completed
Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: Rifampin
Drug: Evacetrapib

Study type

Interventional

Funder types

Industry

Identifiers

NCT01908582
14636
I1V-MC-EIAZ (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

26 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

26 participants in 2 patient groups

Evacetrapib
Experimental group
Description:
Period 1: 130 milligram (mg) evacetrapib administered orally, once on Day 1
Treatment:
Drug: Evacetrapib
Evacetrapib + Rifampin
Experimental group
Description:
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
Treatment:
Drug: Evacetrapib
Drug: Rifampin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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