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

NCT ID: NCT00551317

Last Updated: 2016-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2007-09-30

Brief Summary

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

Detailed Description

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Conditions

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Atherosclerosis

Keywords

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SB480848, Japanese healthy volunteers darapladib,

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Darapladib (SB480848)

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

64 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Honolulu, Hawaii, United States

Site Status

Countries

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United States

Study Documents

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Document Type: Dataset Specification

View Document

Document Type: Informed Consent Form

View Document

Document Type: Annotated Case Report Form

View Document

Document Type: Individual Participant Data Set

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Document Type: Clinical Study Report

View Document

Document Type: Statistical Analysis Plan

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Document Type: Study Protocol

View Document

Related Links

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https://www.clinicalstudydatarequest.com

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

Other Identifiers

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LPL110077

Identifier Type: -

Identifier Source: org_study_id