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GSK2190915A - Bioavailability Study

NCT02224521 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2017-06-14

No results posted yet for this study

Summary

GSK2190915 is a high affinity 5-lipoxygenase-activating protein (FLAP) inhibitor that reduces inflammation in cells.

This study will evaluate three capsule and two tablet formulations to select the optimal formulation for further development. Safety will be assessed through clinical laboratory testing, 12-lead electrocardiogram (ECG), vital signs and Adverse Event/ Serious Adverse Event (AE/ SAE) recording.

Conditions

Interventions

DRUG

GSK2190915 Solution.

Aqueous Solution, 10mg/mL.

DRUG

GSK2190915 Granule Capsule (A)

GSK2190915A granule filled in to Gelatin capsules

DRUG

GSK2190915 Semi-solid Lipid Capsule (B)

GSK2190915A dispersed in a lipid vehicle and filled in to HPMC capsules

DRUG

GSK2190915 Liquid Lipid Capsule (C)

GSK2190915A dissolved in lipid vehicle milled and filled in to Gelatin capsules

DRUG

GSK2190915 Milled Tablet

GSK2190915A granule is blended, compressed into tablets and aqueous film coated

DRUG

GSK2190915 Micronised Tablet

GSK2190915A granule is blended, compressed into tablets and aqueous film coated

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2009-04-20
Primary Completion
2010-06-08
Completion
2010-06-08

Countries

  • United Kingdom

Study Locations

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Entities

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 NCT02224521 on ClinicalTrials.gov