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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00955383 |
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.
Condition | Intervention | Phase |
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Healthy Subjects |
Drug: GSK2190915 Drug: Placebo |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Safety Study |
Official Title: | A Single Centre, Randomised, Double-blind, Placebo-controlled, Four-way Cross Over Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of GSK2190915 in Healthy Japanese Subjects. |
Estimated Enrollment: | 12 |
Study Start Date: | August 2009 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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GSK2190915: Active Comparator
GSK2190915 is a high affinity 5-lipoxygenase-activating protein (FLAP) inhibitor
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Drug: GSK2190915
GSK2190915 is a high affinity 5-lipoxygenase-activating protein (FLAP) inhibitor.
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Placebo: Placebo Comparator |
Drug: Placebo
Matching placebo
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Ages Eligible for Study: | 20 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
This criterion must be followed from the time of the first dose of study medication until 3 months after administration of the last dose (this far exceeds the 5 half lives after administration of the last dose).
Exclusion Criteria:
Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
Germany, Nordrhein-Westfalen | |
GSK Investigational Site | Recruiting |
Neuss, Nordrhein-Westfalen, Germany, 41460 | |
Principal Investigator: Daniel Ecker |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 112359 |
Study First Received: | August 6, 2009 |
Last Updated: | August 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00955383 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Japanese |
Oxymetazoline Phenylephrine Healthy |