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

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Darapladib

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.