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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00551317
First received: October 29, 2007
Last updated: May 31, 2012
Last verified: February 2011
History of Changes

October 29, 2007
May 31, 2012
July 2007
Not Provided
  • - 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
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Atherosclerosis
Drug: Darapladib (SB480848)
Other Name: 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.
 
Completed
18
Not Provided
Not Provided

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.
Male
20 Years to 64 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00551317
LPL110077
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
February 2011

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