MedTrace Logo

A Single Dose Study to Assess the Regional Absorption and Bioavailability of 100mg GSK2190915A

NCT01318980 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2017-08-03

No results posted yet for this study

Summary

GSK2190915 is a high affinity 5-lipoxygenase-activating protein (FLAP) inhibitor that attenuates the production of leukotrienes through the blockage of the first step in the leukotriene pathway, 5-lipoxygenase (5-LO) activation. GSK2190915 inhibits the production of leukotriene B4 (LTB4) and cysteinyl leukotrienes (cysLTs).

This is an open label, 4-way, 4-treatment period, non-randomised, crossover study with an interim analysis. The GSK2190915 formulations used in this study will be: a 100mg and 200mg milled tablet, a 100mg enteric-coated tablet, and a \[14C\] radiolabelled GSK2190915 intravenous solution.

This study aims to determine the pharmacokinetics and absolute bioavailability of GSK2190915 to enable optimisation of suitable formulations to be used in clinical development Fourteen subjects will be dosed to ensure data in 10 at the end of the clinical study. Seven of the subjects will receive an IV microtracer in addition to the other treatments.

Conditions

Interventions

DRUG

GSK2190915 100mg milled tablet

Taken orally

DRUG

[14C] radiolabelled GSK2190915 solution

Microtracer solution

DRUG

GSK2190915 100mg milled tablet administered to the proximal small bowel.

Ground half of a 200mg tablet. Administered via Enterion capsule.

DRUG

GSK2190915 100mg milled tablet administered to the distal small bowel.

Ground half of a 200mg tablet. Administered via Enterion capsule.

DRUG

GSK2190915 100mg enteric-coated tablet.

Taken orally

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2011-03-11
Completion
2011-03-11

Countries

  • United Kingdom

Study Locations

More Related Trials

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 NCT01318980 on ClinicalTrials.gov