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

This study has been completed.

First Received: October 3, 2006 Last Updated: July 8, 2009 History of Changes

Sponsor:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00384917

Purpose

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

Condition	Intervention	Phase
Healthy	Drug: Ketoconazole	Phase I

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 Ketoconazole on Single-Dose Pharmacokinetics of HCV-796

Resource links provided by NLM:

Drug Information available for: Ketoconazole Fungarest HCV 796

U.S. FDA Resources

Further study details as provided by Wyeth:

Primary Outcome Measures:

To evaluate the effects of multiple oral doses of ketoconazole 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 ketoconazole when coadministered to healthy subjects.

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

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00384917

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Study ID Numbers:	3173A1-111
Study First Received:	October 3, 2006
Last Updated:	July 8, 2009
ClinicalTrials.gov Identifier:	NCT00384917 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Anti-Infective Agents
Therapeutic Uses
Antifungal Agents
Ketoconazole
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010