Monotherapy Versus Placebo Over 14 or 17 Days in Healthy and Hepatitis C Infected Adults

A Double-Blind, Parallel, Randomized, Placebo-Controlled, Single and Repeat Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of GSK625433 in Healthy Subjects and in Subjects Who Are Chronically Infected With Hepatitis C.

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00439959

Enrollment

Registered

2007-02-26

Start date

2006-10-31

Completion date

2007-03-31

Last updated

2012-06-04

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

Conditions

Hepatitis C, Hepatitis C, Chronic

Keywords

GSK625433,, Hepatitis C,, metabolic probe,, food-effect,, HCV,, FTIH, polymerase,

Brief summary

This study represents the first administration of GSK625433 in humans. The study is designed to evaluate initial safety and tolerability in healthy adults as well as anti-viral activity in Hepatitis C(HVC) infected adults. The way the human body processes GSK625433 will also be investigated.

Interventions

DRUGGSK625433/placebo

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy males & females * Part 1 ages 18-60 * Part 2 ages 18-50 & 65-80 * Within normal weight range given your height * Negative urine drug and alcohol test * Willing to follow all study procedures

Exclusion criteria

* Any significant abnormal lab, ECG, medical or physical exam finding during screening * Allergy to the study drug * Excessive alcohol intake * Positive HIV or hepatitis B or C result * Use of prescription or non-prescription drugs within one week of study start except for birth control * Blood pressure meds & Tylenol * Pregnant or lactating women

Design outcomes

Primary

Measure	Time frame
Safety parameters: adverse events; telemetry; clinical laboratory values, vital signs, and ECGs. Plasma levels of GSK625433. Change in HCV viral load. Taken throughout the study	17 Days

Secondary

Measure	Time frame
Plasma levels of GSK625433. Metabolic analysis of CYP substrates to estimate enzyme activity. Resistance analysis for subjects with HCV infection. Taken throughout the study	17 Days

Countries

United States

Outcome results

None listed

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