Last updated: 11/04/2018 08:56:34
A study investigating the concentrations of darapladib in blood and the safety of this compound in healthy Japanese men
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single oral doses of darapladib (SB480848) in healthy Japanese male subjects
Trial description: This study is being conducted to provide initial safety, tolerability, PK and PD data that will allow further studies with darapladib in Japanese patients
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
- Safety/tolerability of single oral doses of darapladib
Timeframe: 4, 24 and 96h post-dose
- Primary Pharmacokinetic parameters of single oral doses of darapladib
Timeframe: pre-dose, 0,5, 1, 2, 3, 4, 6, 9 12, 16, 24, 48, 72h post-dose
Secondary outcomes:
-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
Timeframe: Throughout the study
Interventions:
Drug: Darapladib (SB480848)
Enrollment:
18
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Atherosclerosis
Product
darapladib
Collaborators
Not applicable
Study date(s)
July 2007 to September 2007
Type
Interventional
Phase
1
Participation criteria
Sex
Male
Age
20 - 64 years
Accepts healthy volunteers
Yes
- Japanese males, 20-64 years of age, inclusive
- Body weight >50Kg
- History of asthma, anaphylaxis or anaphylactoid reactions, severe allergic responses
- History of sensitivity to heparin or heparin-induced thrombocytopenia
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Honolulu, Hawaii, United States, 96813
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2007-14-09
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Participate in clinical trial
Additional information
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Click hereAccess to clinical trial data by researchers
Visit website