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Completed

NCT Number: NCT00551317

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

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

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Key information

Conditions

Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Vascular Diseases

Age range

20 year–64 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Honolulu, Hawaii, 96813, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Darapladib (SB480848)

Drug

Primary outcomes

  1. - Safety/tolerability of single oral doses of darapladib

    Time frame: 4, 24 and 96h post-dose

  2. - 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 outcomes

  1. -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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Oral Doses of Darapladib (SB480848) in Healthy Japanese Male Subjects

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Oct 30, 2007
Registry last updated
Dec 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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