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

NCT ID: NCT01679639

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2012-12-31

Brief Summary

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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

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Aleglitazar

Group Type EXPERIMENTAL

aleglitazar

Intervention Type DRUG

Single dose of aleglitazar in Periods 1, 2, 3

rifampicin

Intervention Type DRUG

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

Interventions

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aleglitazar

Single dose of aleglitazar in Periods 1, 2, 3

Intervention Type DRUG

rifampicin

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Manchester, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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2012-002274-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BP25561

Identifier Type: -

Identifier Source: org_study_id