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

Roche

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: aleglitazar; Drug: rifampicin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01679639

BP25561

2012-002274-31 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

24 participants in 1 patient group

Aleglitazar

Experimental group

Treatment:

Drug: aleglitazar

Drug: rifampicin