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

NCT00551317 | Completed Phase 1

• 1 other identifier: LPL110077
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atherosclerosis

Keywords

SB480848,; Japanese healthy volunteers; darapladib,

Outcome Measures

Primary Outcomes (2)

• - Safety/tolerability of single oral doses of darapladib

  4, 24 and 96h post-dose

• - Primary Pharmacokinetic parameters of single oral doses of darapladib

  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

  Throughout the study

Interventions

Darapladib (SB480848) DRUG

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Honolulu, Hawaii, 96813, United States

Location

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Atherosclerosis

Interventions

darapladib

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2007
• First Posted: October 30, 2007
• Study Start: July 1, 2007
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: December 5, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)