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Study to Evaluate the Effects of Age & Gender on PK, Safety & Tolerability of HCV-796 Administered to Healthy Subjects

This study has been completed.
Sponsor:
Collaborator:
ViroPharma
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00407173
First received: November 29, 2006
Last updated: April 10, 2008
Last verified: April 2008

November 29, 2006
April 10, 2008
November 2006
June 2007   (final data collection date for primary outcome measure)
To evaluate the pharmacokinetic (PK) profile of HCV-796 in healthy men and women of different ages. [ Time Frame: 7 days ] [ Designated as safety issue: No ]
To evaluate the pharmacokinetic (PK) profile of HCV-796 in healthy men and women of different ages.
Complete list of historical versions of study NCT00407173 on ClinicalTrials.gov Archive Site
To assess the safety and tolerability of a single oral dose of HCV-796 in healthy men and women of different ages. [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]
To assess the safety and tolerability of a single oral dose of HCV-796 in healthy men and women of different ages.
Not Provided
Not Provided
 
Study to Evaluate the Effects of Age & Gender on PK, Safety & Tolerability of HCV-796 Administered to Healthy Subjects
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 Subjects

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 subjects.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
Drug: HCV-796
HCV-796 1000mg single dose
Experimental: 1
HCV-796 1000mg single dose
Intervention: Drug: HCV-796
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
June 2007
June 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00407173
3173A1-112
No
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
ViroPharma
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP