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Trial record 1 of 1 for:    NCT00407173
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Study to Evaluate the Effects of Age & Gender on PK, Safety & Tolerability of HCV-796 Administered to Healthy Subjects

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ClinicalTrials.gov Identifier: NCT00407173
Recruitment Status : Completed
First Posted : December 4, 2006
Last Update Posted : April 14, 2008
Sponsor:
Collaborator:
ViroPharma
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE November 29, 2006
First Posted Date  ICMJE December 4, 2006
Last Update Posted Date April 14, 2008
Study Start Date  ICMJE November 2006
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2007)
To evaluate the pharmacokinetic (PK) profile of HCV-796 in healthy men and women of different ages. [ Time Frame: 7 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 30, 2006)
To evaluate the pharmacokinetic (PK) profile of HCV-796 in healthy men and women of different ages.
Change History Complete list of historical versions of study NCT00407173 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2007)
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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2006)
To assess the safety and tolerability of a single oral dose of HCV-796 in healthy men and women of different ages.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Effects of Age & Gender on PK, Safety & Tolerability of HCV-796 Administered to Healthy Subjects
Official Title  ICMJE 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
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 subjects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE Drug: HCV-796
HCV-796 1000mg single dose
Study Arms  ICMJE Experimental: 1
HCV-796 1000mg single dose
Intervention: Drug: HCV-796
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: November 30, 2006)
48
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2007
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00407173
Other Study ID Numbers  ICMJE 3173A1-112
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE ViroPharma
Investigators  ICMJE
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date April 2008

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