Phase I Study of SB-480848(Darapladib) -Repeat Dose Study in Healthy Japanese Male Subjects-

Phase 1

Completed

• Conditions: Atherosclerosis

• Registration Number: NCT00622830
• Lead Sponsor: GlaxoSmithKline

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-02-13
• Study First Submitted QC: 2008-02-22
• Study First Posted: 2008-02-25
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-02
• Last Update Posted: 2016-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Primary Pharmacokinetic parameters of repeat oral doses of darapladib
Safety/tolerability of repeat oral doses of darapladib

Secondary Outcome Measures

Name	Time	Method
-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

Trial Locations

Locations (1)

GSK Investigational Site; 🇯🇵 Ibaraki, Japan