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

This study is ongoing, but not recruiting participants.

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00384280

Purpose

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

Condition	Intervention	Phase
Healthy	Drug: Rifampin	Phase I

Drug Information available for: Rifampin HCV 796

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Pharmacokinetics Study
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

Further study details as provided by Wyeth:

Primary Outcome Measures:

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:

To assess the safety and tolerability of HCV-796 and rifampin when coadministered to healthy subjects.

Estimated Enrollment:	24
Study Start Date:	September 2006
Estimated Study Completion Date:	October 2006

Eligibility

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00384280

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

Study ID Numbers:	3173A1-110
Study First Received:	October 3, 2006
Last Updated:	February 26, 2007
ClinicalTrials.gov Identifier:	NCT00384280
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Rifampin
Healthy

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Enzyme Inhibitors

Antitubercular Agents
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Leprostatic Agents
Antibiotics, Antitubercular

ClinicalTrials.gov processed this record on January 16, 2009