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

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.

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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