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

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ClinicalTrials.gov Identifier: NCT00500721
Recruitment Status : Completed
First Posted : July 13, 2007
Last Update Posted : April 14, 2008
Sponsor:
Collaborator:
ViroPharma
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: HCV-796 Drug: Desipramine Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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
Study Start Date : June 2007
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Reactions
U.S. FDA Resources


Intervention Details:
    Drug: HCV-796
    HCV-796 500mg BID x 14 days
    Drug: Desipramine

    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.



Primary Outcome Measures :
  1. Pharmacokinetic (PK) [ Time Frame: 21 days ]

Secondary Outcome Measures :
  1. Safety [ Time Frame: 29 days ]


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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 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): NCT00500721


Locations
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19148
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
ViroPharma
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00500721     History of Changes
Other Study ID Numbers: 3173A1-1120
First Posted: July 13, 2007    Key Record Dates
Last Update Posted: April 14, 2008
Last Verified: April 2008

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
healthy subjects

Additional relevant MeSH terms:
Desipramine
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs