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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00551317

Enrollment

Registered

2007-10-30

Start date

2007-07-31

Completion date

2007-09-30

Last updated

2016-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis

Keywords

SB480848,, Japanese healthy volunteers, darapladib,

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

Interventions

DRUGDarapladib (SB480848)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

MALE

Age

20 Years to 64 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	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

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026