A Study To Evaluate The Safety And Tolerability Of SB-656933-AAA Following Repeated Doses In Healthy Adult Subjects
A Randomised, Double-blind, Placebo Controlled, Dose Ascending, Parallel Group Study to Evaluate the Safety, Tolerability, Steady State Pharmacokinetics and Pharmacodynamics of SB-656933-AAA Following Repeated Doses in Healthy Adult Subjects. The Pharmacokinetic Interaction Between Repeated Doses of SB-656933-AAA and Single Dose of Simvastatin Will Also be Assessed
1 other identifier
interventional
36
1 country
1
Brief Summary
To assess safety of SB-656933 following repeat dosing for 14 days.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jun 2007
Shorter than P25 for phase_1
1 active site
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
June 4, 2007
CompletedFirst Submitted
Initial submission to the registry
July 18, 2007
CompletedFirst Posted
Study publicly available on registry
July 20, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 6, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
September 6, 2007
CompletedAugust 3, 2017
August 1, 2017
3 months
July 18, 2007
August 2, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assess safety of SB-656933 after repeat doses.
after repeat doses
Secondary Outcomes (1)
Investigate concentrations of SB-656933 in the body and how long it remains in the body over 14 days of repeat dosing.
14 days of repeat dosing.
Study Arms (3)
Cohort 1
EXPERIMENTALSubjects in Cohort 1 will receive 20 milligrams (mg) of SB-656933-AAA once daily or matching placebo once daily for 14 days.
Cohort 2
EXPERIMENTALSubjects will be administered 40 mg simvastatin on day 1 followed by a washout period of two days. From day 3, the subjects will receive 50 mg of SB-656933-AAA once daily or matching placebo once daily for 14 days. On day 17, subjects will be administered 40 mg simvastatin along with SB-656933-AAA to assess statin interaction.
Cohort 3
EXPERIMENTALSubjects will be administered 100 mg SB-656933-AAA/ day or matching placebo for 14 days. Dosing will initiate after cohort I and II have completed dosing.
Interventions
The doses of SB-656933 (20 mg, 50 mg or 100 mg) will be provided as a combination of 10 mg and 50 mg tablets of SB-656933-AAA. The tablets will be administered orally.
SB-656933-AAA matching placebo tablets will be administered orally.
Eligibility Criteria
You may qualify if:
- Healthy adult female, aged 18-65 years.
- Female must not be able to have children.
- Non-smoking for the last 6 months.
You may not qualify if:
- Any serious medical condition.
- Hepatitis B or C and/or HIV positive.
- Currently on HRT, or other medication except paracetamol.
- Body Mass Index \>30.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (1)
GSK Investigational Site
London, NW10 7NS, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2007
First Posted
July 20, 2007
Study Start
June 4, 2007
Primary Completion
September 6, 2007
Study Completion
September 6, 2007
Last Updated
August 3, 2017
Record last verified: 2017-08