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

Healthy Volunteer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01679639
• Other study ID #: BP25561
• Secondary ID: 2012-002274-31
• Status: Completed
• Phase: Phase 1
• First received: September 1, 2012
• Last updated: November 1, 2016
• Start date: August 2012
• Est. completion date: December 2012

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• aleglitazar
Single dose of aleglitazar in Periods 1, 2, 3
• rifampicin
Single dose in Periods 1 and 2; multiple doses in Period 3

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics: Area under the plasma concentration time curve		Period 1 and 2: Predose and days 1 to 5; Period 3: Days 5 to 12	No
Secondary	Safety: incidence of adverse events		14 weeks	No