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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00551317
Recruitment Status : Completed
First Posted : October 30, 2007
Last Update Posted : December 5, 2016
Information provided by (Responsible Party):

October 29, 2007
October 30, 2007
December 5, 2016
July 2007
September 2007   (Final data collection date for primary outcome measure)
  • - Safety/tolerability of single oral doses of darapladib [ Time Frame: 4, 24 and 96h post-dose ]
  • - 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 ]
Same as current
Complete list of historical versions of study NCT00551317 on ClinicalTrials.gov Archive Site
-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 ]
Same as current
Not Provided
Not Provided
A Study Investigating the Concentrations of Darapladib in Blood and the Safety of This Compound in Healthy Japanese Men
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Oral Doses of Darapladib (SB480848) in Healthy Japanese Male Subjects
This study is being conducted to provide initial safety, tolerability, PK and PD data that will allow further studies with darapladib in Japanese patients
Not Provided
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Drug: Darapladib (SB480848)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
September 2007
September 2007   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Male
20 Years to 64 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP