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

Completed · Phase 1

Conditions studied: Atherosclerosis

In brief

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

Key facts

Study ID

NCT00551317

Run by

GlaxoSmithKline

People needed

18

Starts

2007-07-01

Expected to finish

2007-09-01

Last updated by the study team

2016-12-05

Who can join

Age: 20 and older, up to 64. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Honolulu, Hawaii, United States

Full record on ClinicalTrials.gov

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