Last updated: 11/04/2018 08:14:43
Monotherapy Versus Placebo Over 14 or 17 Days in Healthy and Hepatitis C Infected Adults
GSK study ID
HSP108233
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Terminated (halted prematurely)
Terminated (halted prematurely)
Trial overview
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.
Trial description: 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.
Primary purpose:
Diagnostic
Trial design:
Single Group Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
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
Timeframe: 17 Days
Secondary outcomes:
Plasma levels of GSK625433. Metabolic analysis of CYP substrates to estimate enzyme activity. Resistance analysis for subjects with HCV infection. Taken throughout the study
Timeframe: 17 Days
Interventions:
Drug: GSK625433/placebo
Enrollment:
48
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Hepatitis C, Chronic
Product
GSK625433
Collaborators
Not applicable
Study date(s)
October 2006 to March 2007
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 55 years
Accepts healthy volunteers
Yes
- Healthy males & females
- Part 1 ages 18-60
- Any significant abnormal lab, ECG, medical or physical exam finding during screening
- Allergy to the study drug
Inclusion and exclusion 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
Trial location(s)
Location
GSK Investigational Site
Evansville, Indiana, United States, 47714
Status
Terminated/Withdrawn
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Terminated (halted prematurely)
Actual primary completion date
Not applicable
Actual study completion date
2007-23-03
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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