A Study to Investigate the Effects of Rifampicin on the Pharmacokinetics of Aleglitazar in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: aleglitazar; Drug: rifampicin

• Registration Number: NCT01679639
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This open-label, fixed-sequence, three-period, single group study will evaluate the effects of rifampicin on the pharmacokinetics of aleglitazar in healthy volunteers. Volunteers will receive single doses of aleglitazar in all three periods and single doses of rifampicin in periods 1 and 2, and multiple doses in period 3. The anticipated time on study treatment is up to 14 weeks.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-09-01
• Study First Submitted QC: 2012-09-01
• Study First Posted: 2012-09-06
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

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

Inclusion Criteria

• Healthy volunteers, aged 18 to 55 years inclusive at the time of screening
• Body mass index (BMI) between 18.0 and 35.0 kg/m2 inclusive
• Females must be surgically sterile or use two acceptable methods of contraception
• Non-smoker or currently smoking less than five cigarettes/day and willing to abstain from smoking during the study

Exclusion Criteria

• Any clinically relevant abnormal laboratory test results at screening or on Day -1 of all periods, as judged by the Investigator
• A history of clinically significant disorders (e.g., gastro-intestinal, cardiovascular, hepatic)
• Infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
• An average alcohol intake of more than 14 units per week
• Volunteers diagnosed, or suspected of having porphyria, and subjects with first degree relatives diagnosed, or suspected of having porphyria
• Diagnosis of Gilberts Syndrome
• A positive screen for drugs of abuse at screening or on admission to the clinical unit

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aleglitazar	rifampicin	-
Aleglitazar	aleglitazar	-

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics: Area under the plasma concentration time curve	Period 1 and 2: Predose and days 1 to 5; Period 3: Days 5 to 12

Secondary Outcome Measures

Name	Time	Method
Safety: incidence of adverse events	14 weeks