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
  Purpose

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


Condition Intervention Phase
Atherosclerosis
Drug: Darapladib (SB480848)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Oral Doses of Darapladib (SB480848) in Healthy Japanese Male Subjects

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • - 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 ]

Secondary Outcome Measures:
  • -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 ]

Enrollment: 18
Study Start Date: July 2007
Intervention Details:
    Drug: Darapladib (SB480848)
    Other Name: Darapladib (SB480848)
  Eligibility

Ages Eligible for Study:   20 Years to 64 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00551317

Locations
United States, Hawaii
GSK Investigational Site
Honolulu, Hawaii, United States, 96813
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00551317     History of Changes
Other Study ID Numbers: LPL110077
Study First Received: October 29, 2007
Last Updated: May 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
SB480848,
Japanese healthy volunteers
darapladib,

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Darapladib
Phospholipase A2 Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 15, 2014