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

GlaxoSmithKline (GSK) logo

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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