A Study Investigating the Concentrations of Darapladib in Blood and the Safety of This Compound in Healthy Japanese Men
Phase 1
Completed
- Conditions
- Atherosclerosis
- Registration Number
- NCT00551317
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
This study is being conducted to provide initial safety, tolerability, PK and PD data that will allow further studies with darapladib in Japanese patients
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 18
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method - Safety/tolerability of single oral doses of darapladib 4, 24 and 96h post-dose - Primary Pharmacokinetic parameters of single oral doses of darapladib pre-dose, 0,5, 1, 2, 3, 4, 6, 9 12, 16, 24, 48, 72h post-dose
- Secondary Outcome Measures
Name Time Method -Secondary PK parameters -PK parameters of SB553253 -inhibition of Lp-PLA2 activity -description of plasma concentration-Lp-PLA2 activity inhibition relationship after single oral doses of darapladib. all measured same timepoints as primary PK Throughout the study
Trial Locations
- Locations (1)
GSK Investigational Site
🇺🇸Honolulu, Hawaii, United States