Study Evaluating the Pharmacokinetics of the Potential Drug Interaction Between HCV-796 and Desipramine - Tabular View

Tracking Information

First Received Date ^ICMJE

July 9, 2007

Last Updated Date

April 10, 2008

Start Date ^ICMJE

June 2007

Primary Completion Date

August 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Pharmacokinetic (PK) [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

PK and safety

Change History

Complete list of historical versions of study NCT00500721 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Safety [ Time Frame: 29 days ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Study Evaluating the Pharmacokinetics of the Potential Drug Interaction Between HCV-796 and Desipramine

Official Title ^ICMJE

An Open-Label, Single-Dose Desipramine, Multiple-Dose HCV-796, Sequential 3-Period Study to Determine the Pharmacokinetics of the Potential Drug Interaction Between HCV-796 and Desipramine

Brief Summary

To evaluate the potential pharmacokinetic (PK) interaction of multiple oral doses of HCV-796 and a single dose of desipramine when coadministered to healthy subjects.

Detailed Description

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Other, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Pharmacokinetics Study

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Drug: HCV-796
Drug: Desipramine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

August 2007

Primary Completion Date

August 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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 ECG.

Gender

Both

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00500721

Responsible Party

Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth

Study ID Numbers ^ICMJE

3173A1-1120

Study Sponsor ^ICMJE

Wyeth

Collaborators ^ICMJE

ViroPharma

Investigators ^ICMJE

Study Director:

Medical Monitor

Wyeth

Information Provided By

Wyeth

Verification Date

April 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP