NCT00622830CompletedPhase 1
Phase I Study of SB-480848 (Darapladib) -A Double Blind, Randomised, Placebo-controlled, Parallel-group, Repeat Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SB-480848 in Healthy Japanese Male Subjects-
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 18
- Locations
- 2
- Primary Endpoint
- Primary Pharmacokinetic parameters of repeat oral doses of darapladib
Study Overview
Brief Summary
This study is being conducted to provide safety, tolerability, PK and PD data in repeat dosing that will allow further studies with darapladib in Japanese patients
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 20 Years to 64 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Primary Pharmacokinetic parameters of repeat oral doses of darapladib
Safety/tolerability of repeat oral doses of darapladib
Secondary Outcomes
- -Secondary PK parameters
- Plasma Lp-PLA2 activity, expressed in terms of percent inhibition relative to baseline
- -inhibition of Lp-PLA2 activity
- -description of plasma concentration-Lp-PLA2 activity inhibition relationship after repeat oral doses of darapladib. all measured same timepoints as primary
- -PK parameters of SB553253
- Tmax, and t1/2 of SB-480848 and AUC, Cmax, t1/2 and Tmax of the pharmacologically active metabolite SB-553253 (as data permit)
- Estimation of PK/PD parameters and their associated variability, appropriate to the final models
Investigators
Study Sites (2)
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