Status:
COMPLETED
Study to Evaluate the Effects of Age & Gender on PK, Safety & Tolerability of HCV-796 Administered to Healthy Subjects
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Collaborating Sponsors:
ViroPharma
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study is an open-label, single-dose, parallel group study to evaluate the effects of age and gender on the pharmacokinetics, safety, and tolerability of HCV-796 administered orally to healthy sub...
Eligibility Criteria
Inclusion
- Inclusion:
- Men or nonlactating and nonpregnant women, aged 18 to 45, and \>65 years.
- Men must agree to practice barrier contraception for 12 weeks after the last test article administration.
- Estimated (calculated) creatinine clearance must be within the age-appropriate normal range.
- Exclusion:
- History of seizures.
- History of rhabdomyolysis.
- History of thyroid disease.
Exclusion
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2007
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00407173
Start Date
November 1 2006
End Date
June 1 2007
Last Update
April 14 2008
Active Locations (2)
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1
Gainesville, Florida, United States, 32608
2
Philadelphia, Pennsylvania, United States, 19148