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

NCT ID: NCT00407173

Last Updated: 2008-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2007-06-30

Brief Summary

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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

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

HCV-796 1000mg single dose

Group Type EXPERIMENTAL

HCV-796

Intervention Type DRUG

HCV-796 1000mg single dose

Interventions

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HCV-796

HCV-796 1000mg single dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ViroPharma

INDUSTRY

Sponsor Role collaborator

Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Wyeth

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Locations

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Gainesville, Florida, United States

Site Status

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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3173A1-112

Identifier Type: -

Identifier Source: org_study_id