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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01679639

Enrollment

Registered

2012-09-06

Start date

2012-08-31

Completion date

2012-12-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

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.

Interventions

DRUGaleglitazar

Single dose of aleglitazar in Periods 1, 2, 3

DRUGrifampicin

Single dose in Periods 1 and 2; multiple doses in Period 3

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Safety: incidence of adverse events	14 weeks

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026