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HCV-796 and Midazolam Drug Interaction Study in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT00410254
Recruitment Status : Completed
First Posted : December 12, 2006
Last Update Posted : December 5, 2007
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary:
To evaluate the potential PK interaction of multiple oral doses of HCV-796 and a single oral dose of midazolam when coadministered to healthy subjects.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Single-Dose Midazolam, Multiple-Dose HCV-796, Sequential 3-Period Study to Determine the Pharmacokinetics of the Potential Drug Interaction Between HCV-796 and Midazolam
Study Start Date : June 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




Primary Outcome Measures :
  1. Safety PK


Information from the National Library of Medicine

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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 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): NCT00410254


Locations
United States, Florida
Gainesville, Florida, United States, 32608
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19148
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer

ClinicalTrials.gov Identifier: NCT00410254     History of Changes
Other Study ID Numbers: 3173A1-109
First Posted: December 12, 2006    Key Record Dates
Last Update Posted: December 5, 2007
Last Verified: December 2007

Additional relevant MeSH terms:
Midazolam
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action