NCT00439959

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2006

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 26, 2007

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

June 4, 2012

Status Verified

March 1, 2011

Enrollment Period

5 months

First QC Date

February 22, 2007

Last Update Submit

May 31, 2012

Conditions

Hepatitis C, ChronicHepatitis C

Keywords

GSK625433,Hepatitis C,metabolic probe,food-effect,HCV,FTIHpolymerase,

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Interventions

GSK625433/placeboDRUG

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

Evansville, Indiana, 47714, United States

Location

MeSH Terms

Conditions

Hepatitis C, ChronicHepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2007

First Posted

February 26, 2007

Study Start

October 1, 2006

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

June 4, 2012

Record last verified: 2011-03

Locations

US(1)