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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01679639
Recruitment Status : Completed
First Posted : September 6, 2012
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: aleglitazar Drug: rifampicin Phase 1

Study Design
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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

Resource links provided by the National Library of Medicine

Drug Information available for: Rifampin

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Safety: incidence of adverse events [ Time Frame: 14 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United Kingdom
Manchester, United Kingdom, M13 9WL
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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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
Additional relevant MeSH terms:
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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