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OpenTrials
Completed

NCT Number: NCT00500721

Study Evaluating 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.

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Philadelphia, Pennsylvania, 19148, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HCV-796

Drug

HCV-796 500mg BID x 14 days

Desipramine

Drug

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 outcomes

  1. Pharmacokinetic (PK)

    Time frame: 21 days

Secondary outcomes

  1. Safety

    Time frame: 29 days

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Collaborators

  • ViroPharma

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Jul 13, 2007
Registry last updated
Apr 14, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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