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

GlaxoSmithKline (GSK)

Status and phase: Terminated; Phase 1

Conditions: Hepatitis C, Chronic; Hepatitis C

Treatments: Drug: GSK625433/placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00439959

HSP108233

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind