A Study of Evacetrapib in Japanese and Non-Japanese Participants

Healthy Volunteers Clinical Trial

Official title:

Effect of Evacetrapib on the Pharmacokinetics of Pravastatin in Healthy Japanese and Non-Japanese Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01958489
• Other study ID #: 14625
• Secondary ID: I1V-MC-EIAW
• Status: Completed
• Phase: Phase 1
• Start date: October 2013
• Est. completion date: January 2014

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Evacetrapib
Administered orally
• Pravastatin
Administered orally

Locations

Country	Name	City	State
United Kingdom	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity [AUC(0-8)] 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
Primary	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