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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 1

Conditions

Atherosclerosis

Treatments

Drug: Darapladib (SB480848)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00551317

LPL110077

Details and patient eligibility

About

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

Enrollment

18 patients

Sex

Male

Ages

20 to 64 years old

Volunteers

Accepts Healthy Volunteers

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.