- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00500721
Study Evaluating the Pharmacokinetics of the Potential Drug Interaction Between HCV-796 and Desipramine
April 10, 2008 updated by: Wyeth is now a wholly owned subsidiary of Pfizer
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
22
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19148
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pharmacokinetic (PK)
Time Frame: 21 days
|
21 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety
Time Frame: 29 days
|
29 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2007
Primary Completion (Actual)
August 1, 2007
Study Completion (Actual)
August 1, 2007
Study Registration Dates
First Submitted
July 9, 2007
First Submitted That Met QC Criteria
July 11, 2007
First Posted (Estimate)
July 13, 2007
Study Record Updates
Last Update Posted (Estimate)
April 14, 2008
Last Update Submitted That Met QC Criteria
April 10, 2008
Last Verified
April 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Antidepressive Agents
- Antidepressive Agents, Tricyclic
- Adrenergic Uptake Inhibitors
- Desipramine
Other Study ID Numbers
- 3173A1-1120
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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