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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00407173

Enrollment

Registered

2006-12-04

Start date

2006-11-30

Completion date

2007-06-30

Last updated

2008-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DRUGHCV-796

HCV-796 1000mg single dose

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion 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.

Design outcomes

Primary

Measure	Time frame
To evaluate the pharmacokinetic (PK) profile of HCV-796 in healthy men and women of different ages.	7 days

Secondary

Measure	Time frame
To assess the safety and tolerability of a single oral dose of HCV-796 in healthy men and women of different ages.	15 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026