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

Wyeth

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: HCV-796

Study type: Interventional

Funder types: Industry

Identifiers

NCT00407173

3173A1-112

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

1

Experimental group

Description:

HCV-796 1000mg single dose

Treatment:

Drug: HCV-796