A Study Investigating the Concentrations of Darapladib in Blood and the Safety of This Compound in Healthy Japanese Men

This study has been completed.

First Received: October 29, 2007 Last Updated: October 15, 2008 History of Changes

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00551317

Purpose

This study is being conducted to provide initial safety, tolerability, PK and PD data that will allow further studies with darapladib in Japanese patients

Condition	Intervention	Phase
Atherosclerosis	Drug: Darapladib (SB480848)	Phase I

Drug Information available for: Darapladib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Crossover Assignment, Pharmacokinetics/Dynamics Study
Official Title:	A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Oral Doses of Darapladib (SB480848) in Healthy Japanese Male Subjects

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

- Safety/tolerability of single oral doses of darapladib [ Time Frame: 4, 24 and 96h post-dose ]
- Primary Pharmacokinetic parameters of single oral doses of darapladib [ Time Frame: pre-dose, 0,5, 1, 2, 3, 4, 6, 9 12, 16, 24, 48, 72h post-dose ]

Secondary Outcome Measures:

-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 [ Time Frame: Throughout the study ]

Enrollment:	18
Study Start Date:	July 2007

Eligibility

Ages Eligible for Study:	20 Years to 64 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion criteria:

Japanese males, 20-64 years of age, inclusive
Body weight >50Kg
Body Mass Index (BMI): 18-28
Subjects must have lived outside of Japan no more than 10 years
Non-smoker or smokes fewer than 10 cigarettes/day

Exclusion criteria:

History of asthma, anaphylaxis or anaphylactoid reactions, severe allergic responses
History of sensitivity to heparin or heparin-induced thrombocytopenia
History of alcohol/drug abuse or dependence within 12 months of the study
Positive syphilis, HIV antibody, Hepatitis B, Hepatitis C
History of cholecystectomy or biliary tract disease or history of liver disease
Participation in a clinical study within 30 days prior to first dose
Subject has been exposed to more than 4 chemical entities within 12 months
Positive urine drug and alcohol at screening
Subject has any medical history or clinically relevant abnormality that would make the subject ineligible for inclusion due to safety reasons.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00551317

Locations

United States, Hawaii
GSK Investigational Site
Honolulu, Hawaii, United States, 96813

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	LPL110077
Study First Received:	October 29, 2007
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00551317 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

SB480848,
darapladib,
Japanese healthy volunteers

Study placed in the following topic categories:

Arterial Occlusive Diseases
Atherosclerosis
Vascular Diseases
Healthy
Arteriosclerosis

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Atherosclerosis
Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis

ClinicalTrials.gov processed this record on May 06, 2009