Completed

An Open-label, Fixed-sequence, Three-period, Single Group Study to Investigate the Effects of Rifampicin as an OATP1B1 Inhibitor and a CYP2C8 Inducer on the Pharmacokinetics of Aleglitazar in Healthy Subjects

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What is being tested

aleglitazar

+ rifampicin

Drug
Who is being recruted

From 18 to 55 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Phase 1
Interventional
Study Start: August 2012
See protocol details

Summary

Principal SponsorHoffmann-La Roche
Last updated: November 2, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01679639
Principal SponsorHoffmann-La Roche
Last updated: November 2, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

24 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate
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
Healthy volunteers, aged 18 to 55 years inclusive at the time of screening
Non-smoker or currently smoking less than five cigarettes/day and willing to abstain from smoking during the study
7 exclusion criteria prevent from participating
A history of clinically significant disorders (e.g., gastro-intestinal, cardiovascular, hepatic)
A positive screen for drugs of abuse at screening or on admission to the clinical unit
An average alcohol intake of more than 14 units per week
Any clinically relevant abnormal laboratory test results at screening or on Day -1 of all periods, as judged by the Investigator
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Manchester, United KingdomOpen in Google Maps
CompletedOne Study Center