A Study to Investigate the Effects of Rifampicin on the Pharmacokinetics of Aleglitazar in Healthy Volunteers
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ClinicalTrials.gov Identifier: NCT01679639 |
Recruitment Status :
Completed
First Posted : September 6, 2012
Last Update Posted : November 2, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy Volunteer | Drug: aleglitazar Drug: rifampicin | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 24 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
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 |
Study Start Date : | August 2012 |
Actual Primary Completion Date : | December 2012 |
Actual Study Completion Date : | December 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: Aleglitazar |
Drug: aleglitazar
Single dose of aleglitazar in Periods 1, 2, 3 Drug: rifampicin Single dose in Periods 1 and 2; multiple doses in Period 3 |
- Pharmacokinetics: Area under the plasma concentration time curve [ Time Frame: Period 1 and 2: Predose and days 1 to 5; Period 3: Days 5 to 12 ]
- Safety: incidence of adverse events [ Time Frame: 14 weeks ]

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01679639
United Kingdom | |
Manchester, United Kingdom, M13 9WL |
Study Director: | Clinical Trials | Hoffmann-La Roche |
Responsible Party: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT01679639 |
Other Study ID Numbers: |
BP25561 2012-002274-31 ( EudraCT Number ) |
First Posted: | September 6, 2012 Key Record Dates |
Last Update Posted: | November 2, 2016 |
Last Verified: | November 2016 |
Rifampin Antibiotics, Antitubercular Antitubercular Agents Anti-Bacterial Agents Anti-Infective Agents Leprostatic Agents Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers Cytochrome P-450 CYP2C8 Inducers Cytochrome P-450 CYP2C19 Inducers Cytochrome P-450 CYP2C9 Inducers Cytochrome P-450 CYP3A Inducers |