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NCT01908582 Clinical Trial

A Study of Evacetrapib and Rifampin in Healthy Participants

Healthy Volunteers Clinical Trial

Official title:
Effect of Rifampin on the Pharmacokinetics of Evacetrapib in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01908582
Other study ID # 14636
Secondary ID I1V-MC-EIAZ
Status Completed
Phase Phase 1
First received
Last updated
Start date July 2013
Est. completion date September 2013

Study information
Verified date February 2018
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 26
Est. completion date September 2013
Est. primary completion date September 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Evacetrapib
Administered orally
• Rifampin
Administered orally

Locations
Country Name City State
United States 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

Sponsors (1)
Lead Sponsor Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary Pharmacokinetics, Area Under the Plasma Concentration-Time Curve From Time 0 Hour (h) to Infinity (AUC0-8) 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
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