A Study Investigating the Concentrations of Darapladib in... | NCT00551317

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

NCT00551317

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

Dec 5, 2016Estimated

Enrollment

18Actual

Phase

Phase 1

Conditions

Atherosclerosis

Interventions

Darapladib (SB480848)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Jul 2007

Primary Completion Date

Sep 2007Actual

Completion Date

Sep 2007Actual

First Submitted Date

Oct 29, 2007

First Submission Date that Met QC Criteria

Oct 29, 2007

First Posted Date

Oct 30, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 2, 2016

Last Update Posted Date

Dec 5, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Name	Type	Description	Arm Group Labels	Other Names
Darapladib (SB480848)	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
- 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

Measure	Description	Time Frame
-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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Honolulu	Hawaii	96813	United States

References Module

Citations

Not provided

ID	Term
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases