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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00500721
Recruitment Status : Completed
First Posted : July 13, 2007
Last Update Posted : April 14, 2008
Sponsor:
Collaborator:
Information provided by:

July 9, 2007
July 13, 2007
April 14, 2008
June 2007
August 2007   (Final data collection date for primary outcome measure)
Pharmacokinetic (PK) [ Time Frame: 21 days ]
PK and safety
Complete list of historical versions of study NCT00500721 on ClinicalTrials.gov Archive Site
Safety [ Time Frame: 29 days ]
Not Provided
Not Provided
Not Provided
 
Study Evaluating the Pharmacokinetics of the Potential Drug Interaction Between HCV-796 and Desipramine
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
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Healthy
  • 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.

Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
August 2007
August 2007   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00500721
3173A1-1120
No
Not Provided
Not Provided
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
ViroPharma
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
April 2008

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