A Study of Evacetrapib in Japanese and Non-Japanese Participants

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Pravastatin; Drug: Evacetrapib

• Registration Number: NCT01958489
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The main purpose of this study is to look at the effect of evacetrapib on pravastatin levels in the blood when both drugs are taken at the same time. The study will also assess how well the body handles evacetrapib and pravastatin when given at the same time.

This study has two periods in fixed order. Each participant will enroll in both periods. This study will last approximately 25 days, not including screening.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-07
• Study First Submitted QC: 2013-10-07
• Study First Posted: 2013-10-09
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2018-02
• Results First Submitted: 2018-02-18
• Results First Submitted QC: 2018-02-18
• Last Update Submitted: 2018-02-18
• Results First Posted: 2018-10-09
• Last Update Posted: 2018-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Overtly healthy participants, as determined by medical history and physical examination
• Have a body mass index of 18 to 32 kilograms per square meter (kg/m²)
• Japanese participants must be first generation Japanese

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pravastatin	Pravastatin	Single 40 milligram (mg) oral dose of pravastatin administered on Day 1.
Evacetrapib + Pravastatin	Evacetrapib	Oral doses of 130 mg evacetrapib administered once daily on Days 2 through 11, with a single oral dose of 40 mg pravastatin coadministered on Day 11.
Evacetrapib + Pravastatin	Pravastatin	Oral doses of 130 mg evacetrapib administered once daily on Days 2 through 11, with a single oral dose of 40 mg pravastatin coadministered on Day 11.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Pravastatin	Day 1 and Day 11: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours postdose
PK: Time of Maximum Observed Concentration (Tmax) of Pravastatin	Day 1 and Day 11: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours postdose
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-∞)] of Pravastatin	Day 1 and Day 11: Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours postdose

Trial Locations

Locations (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.; 🇬🇧 Leeds, West Yorkshire, United Kingdom