Back to resultsMonotherapy Versus Placebo Over 14 or 17 Days in Healthy and Hepatitis C Infected Adults
Primary Purpose
Hepatitis C, Chronic, Hepatitis C
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
GSK625433/placebo
Sponsored by
About this trial
This is an interventional diagnostic trial for Hepatitis C, Chronic focused on measuring GSK625433,, Hepatitis C,, metabolic probe,, food-effect,, HCV,, FTIH, polymerase,
Eligibility Criteria
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
Sites / Locations
- GSK Investigational Site
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Plasma levels of GSK625433. Metabolic analysis of CYP substrates to estimate enzyme activity. Resistance analysis for subjects with HCV infection. Taken throughout the study
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00439959
Brief Title
Monotherapy Versus Placebo Over 14 or 17 Days in Healthy and Hepatitis C Infected Adults
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Terminated
Study Start Date
October 2006 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Chronic, Hepatitis C
Keywords
GSK625433,, Hepatitis C,, metabolic probe,, food-effect,, HCV,, FTIH, polymerase,
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
GSK625433/placebo
Primary Outcome Measure Information:
Title
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
Time Frame
17 Days
Secondary Outcome Measure Information:
Title
Plasma levels of GSK625433. Metabolic analysis of CYP substrates to estimate enzyme activity. Resistance analysis for subjects with HCV infection. Taken throughout the study
Time Frame
17 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
12. IPD Sharing Statement
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Monotherapy Versus Placebo Over 14 or 17 Days in Healthy and Hepatitis C Infected Adults
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