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

Sponsor:	Wyeth
Collaborator:	ViroPharma
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00500721

Purpose

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.

Condition	Intervention	Phase
Healthy	Drug: HCV-796 Drug: Desipramine	Phase I

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Pharmacokinetics Study
Official Title:	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

Resource links provided by NLM:

Drug Information available for: Desipramine Desipramine hydrochloride HCV 796

U.S. FDA Resources

Further study details as provided by Wyeth:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	22
Study Start Date:	June 2007
Study Completion Date:	August 2007
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Intervention Details:

HCV-796 500mg BID x 14 days

Period 1: Single oral dose of desipramine (50 mg) on day 1. No test article administration on days 2 to 6.

Period 2: Multiple oral doses of HCV-796 (500 mg) every 12 hours on days 1 to 9.

Period 3: Multiple oral doses of HCV-796 (500 mg) every 12 hours on days 10 to 14 and a single oral dose of desipramine (50 mg) on day 10.

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 ECG.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00500721

Locations

United States, Pennsylvania

Philadelphia, Pennsylvania, United States, 19148

Sponsors and Collaborators

Wyeth

ViroPharma

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3173A1-1120
Study First Received:	July 9, 2007
Last Updated:	April 10, 2008
ClinicalTrials.gov Identifier:	NCT00500721 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

healthy subjects

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs

Enzyme Inhibitors
Desipramine
Pharmacologic Actions
Antidepressive Agents, Tricyclic
Therapeutic Uses
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on November 27, 2009