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

Hepatitis C Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00439959
• Other study ID #: HSP108233
• Status: Terminated
• Phase: Phase 1
• First received: February 22, 2007
• Last updated: May 31, 2012
• Start date: October 2006
• Est. completion date: March 2007

Study information

• Verified date: March 2011
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 48
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic

Intervention

Drug:
• GSK625433/placebo

Locations

Country	Name	City	State
United States	GSK Investigational Site	Evansville	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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