HCV-796 and Midazolam Drug Interaction Study in Healthy Subjects

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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...

Brief Summary

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”

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.

  • Study Type: Interventional
  • Study Design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Intervention(s) in this Clinical Trial

  • Drug: HCV-796
  • Drug: midazolam

Outcome Measures for this Clinical Trial

Primary Measures

  • Safety PK

Criteria for Participation in this Clinical Trial

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 50 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Clinical Trial Investigator Information

Lead Investigator: Wyeth is now a wholly owned subsidiary of Pfizer Industry

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Wyeth is now a wholly owned subsidiary of Pfizer  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00410254

Study ID Number: 3173A1-109

ClinicalTrials.gov Identifier: NCT00410254

Health Authority: United States: Food and Drug Administration

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00410254