Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
GlaxoSmithKline |
---|---|
Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00622830 |
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
Condition | Intervention | Phase |
---|---|---|
Atherosclerosis |
Drug: SB-480848 (Darapladib) |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | 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- |
Estimated Enrollment: | 18 |
Study Start Date: | January 2008 |
Study Completion Date: | March 2008 |
Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 20 Years to 64 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion criteria:
Exclusion criteria:
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | LPL110736 |
Study First Received: | February 13, 2008 |
Last Updated: | October 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00622830 History of Changes |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
SB480848, darapladib, Japanese healthy volunteers |
Arterial Occlusive Diseases Atherosclerosis Vascular Diseases Healthy Arteriosclerosis |
Arterial Occlusive Diseases Atherosclerosis Vascular Diseases Cardiovascular Diseases Arteriosclerosis |