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GSK2190915 Safety and Pharmacokinetic Study in Healthy Japanese Subjects

NCT00955383 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2017-06-14

No results posted yet for this study

Summary

GSK2190915 is currently in development for the treatment of asthma. This study aims to assess the safety and tolerability of single doses of GSK2190915 in healthy Japanese subjects. The study will also look at the pharmacokinetics (PK) and pharmacodynamics (PD) of single doses of GSK2190915 and aims to characterise the PK/PD relationship in healthy Japanese subjects. Twelve healthy Japanese subjects will take part in this single escalating dose study and subjects will receive one of five possible treatments, 10 mg, 50 mg, 150 mg, 450 mg GSK2190915 or placebo in each treatment period. Blood samples (for safety, pharmacokinetics and pharmacodynamics), urine samples (for safety and pharmacodynamics) and ECGs, blood pressure readings, physical examinations and a review of adverse events will take place at a number of timepoints pre and post each dose. A minimum 7 day washout between treatment periods will be required. Regardless if a subject completes or prematurely withdraws from the study, a follow up visit will be completed 7-10 days following last dose.

Conditions

Interventions

DRUG

GSK2190915

GSK2190915 is a high affinity 5-lipoxygenase-activating protein (FLAP) inhibitor.

DRUG

Placebo

Matching placebo

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-08-14
Primary Completion
2009-10-12
Completion
2009-10-12

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00955383 on ClinicalTrials.gov