Last updated: 11/04/2018 05:59:57
A Study To Evaluate The Safety And Tolerability Of SB-656933-AAA Following Repeated Doses In Healthy Adult Subjects
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: 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
Trial description: To assess safety of SB-656933 following repeat dosing for 14 days.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Assess safety of SB-656933 after repeat doses.
Timeframe: after repeat doses
Secondary outcomes:
Investigate concentrations of SB-656933 in the body and how long it remains in the body over 14 days of repeat dosing.
Timeframe: 14 days of repeat dosing.
Interventions:
Drug: SB-656933-AAA
Drug: Matching placebo
Drug: Simvastatin
Enrollment:
36
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
elubrixin
Collaborators
Not applicable
Study date(s)
June 2007 to September 2007
Type
Interventional
Phase
1
Participation criteria
Sex
Female
Age
18 - 65 years
Accepts healthy volunteers
Yes
- Healthy adult female, aged 18-65 years.
- Female must not be able to have children.
- Any serious medical condition.
- Hepatitis B or C and/or HIV positive.
Inclusion and exclusion criteria
Inclusion criteria:
- Healthy adult female, aged 18-65 years.
- Female must not be able to have children.
- Non-smoking for the last 6 months.
Exclusion criteria:
- Any serious medical condition.
- Hepatitis B or C and/or HIV positive.
- Currently on HRT, or other medication except paracetamol.
- Body Mass Index >30.
Trial location(s)
Location
GSK Investigational Site
London, United Kingdom, NW10 7NS
Status
Terminated/Withdrawn
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2007-06-09
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
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Additional information
Results for study CR2100609 can be found on the GSK Clinical Study Register.
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