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

Atherosclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00551317
• Other study ID #: LPL110077
• Status: Completed
• Phase: Phase 1
• First received: October 29, 2007
• Last updated: December 2, 2016
• Start date: July 2007
• Est. completion date: September 2007

Study information

• Verified date: December 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 64 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis

Intervention

Drug:
• Darapladib (SB480848)

Locations

Country	Name	City	State
United States	GSK Investigational Site	Honolulu	Hawaii

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	- Safety/tolerability of single oral doses of darapladib		4, 24 and 96h post-dose
Primary	- 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	-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

External 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.