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Study to Determine the Impact of Multiple Doses of Rifampin on Single-dose Pharmacokinetics of HCV-796

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ClinicalTrials.gov Identifier: NCT00384280
Recruitment Status : Completed
First Posted : October 6, 2006
Last Update Posted : August 12, 2009
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary:
An open label, 2-period, sequential study to determine the impact of multiple doses of rifampin on single-dose pharmacokinetics of HCV-796

Condition or disease Intervention/treatment Phase
Healthy Drug: Rifampin Phase 1

Study Type : Interventional  (Clinical Trial)
Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, 2-period, Sequential Study to Determine the Impact of Multiple Doses of Rifampin on Single-dose Pharmacokinetics of HCV-796
Study Start Date : September 2006
Actual Primary Completion Date : November 2006
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Rifampin




Primary Outcome Measures :
  1. To evaluate the effects of multiple oral doses of rifampin on the pharmacokinetic (PK) profile of a single oral dose of HCV-796 in healthy subjects.

Secondary Outcome Measures :
  1. To assess the safety and tolerability of HCV-796 and rifampin when coadministered to healthy subjects.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG).

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): NCT00384280


Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer

ClinicalTrials.gov Identifier: NCT00384280     History of Changes
Other Study ID Numbers: 3173A1-110
First Posted: October 6, 2006    Key Record Dates
Last Update Posted: August 12, 2009
Last Verified: August 2009

Additional relevant MeSH terms:
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