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

Wyeth is now a wholly owned subsidiary of Pfizer48 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

HCV-796DRUG

HCV-796 1000mg single dose

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

Unnamed facility

Gainesville, Florida, United States

Unnamed facility

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

To evaluate the pharmacokinetic (PK) profile of HCV-796 in healthy men and women of different ages.

Time frame: 7 days

Secondary Outcomes

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

Data from ClinicalTrials.gov

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