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:
Wyeth is now a wholly owned subsidiary of Pfizer
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
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | November 29, 2006 | ||||
| Last Updated Date | April 10, 2008 | ||||
| Start Date ICMJE | November 2006 | ||||
| Primary Completion Date | June 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE |
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 |
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 ] | ||||
| Original Secondary Outcome Measures ICMJE |
To assess the safety and tolerability of a single oral dose of HCV-796 in healthy men and women of different ages. | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Healthy | ||||
| Intervention ICMJE | Drug: HCV-796
HCV-796 1000mg single dose |
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| Study Arm (s) | Experimental: 1
HCV-796 1000mg single dose
Intervention: Drug: HCV-796 |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 48 | ||||
| Completion Date | June 2007 | ||||
| Primary Completion Date | June 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion:
Exclusion:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00407173 | ||||
| Other Study ID Numbers ICMJE | 3173A1-112 | ||||
| Has Data Monitoring Committee | No | ||||
| 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 |
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| Information Provided By | Wyeth is now a wholly owned subsidiary of Pfizer | ||||
| Verification Date | April 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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