Back to resultsA Study Investigating the Concentrations of Darapladib in Blood and the Safety of This Compound in Healthy Japanese Men
Primary Purpose
Atherosclerosis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Darapladib (SB480848)
Sponsored by
About this trial
This is an interventional treatment trial for Atherosclerosis focused on measuring SB480848,, Japanese healthy volunteers, darapladib,
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.
Sites / Locations
- GSK Investigational Site
Outcomes
Primary Outcome Measures
- Safety/tolerability of single oral doses of darapladib
- Primary Pharmacokinetic parameters of single oral doses of darapladib
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00551317
Brief Title
A Study Investigating the Concentrations of Darapladib in Blood and the Safety of This Compound in Healthy Japanese Men
Official Title
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Oral Doses of Darapladib (SB480848) in Healthy Japanese Male Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis
Keywords
SB480848,, Japanese healthy volunteers, darapladib,
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Darapladib (SB480848)
Primary Outcome Measure Information:
Title
- Safety/tolerability of single oral doses of darapladib
Time Frame
4, 24 and 96h post-dose
Title
- 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 Measure Information:
Title
-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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
LPL110077
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
LPL110077
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
LPL110077
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
LPL110077
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
LPL110077
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
LPL110077
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
LPL110077
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
A Study Investigating the Concentrations of Darapladib in Blood and the Safety of This Compound in Healthy Japanese Men
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