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A Study to Assess the Relative Bioavailability of Four New Formulations of GSK1605786 in Healthy Subjects

2014-08-27 03:14:01 | BioPortfolio

Summary

This is an open-label, single dose, randomized, five-period, crossover study in healthy volunteers to assess the relative bioavailability of four GSK developed oral formulations of GSK1605786 relative to the capsule formulation administered in the ChemoCentryx Phase IIb, PROTECT-1 Study and ChemoCentryx Thorough QT/QTc Study.

Approximately 24 subjects will be randomized to receive a single 500 mg dose of each of the five formulations of GSK1605786 after a standard breakfast. Serial pharmacokinetic samples will be collected following each dose and safety assessments will be performed. The relative bioavailability of the GSK capsule formulation will be compared to the ChemoCentryx formulation while the relative bioavailability the three other formulations will be compared to the GSK capsule formulation intended for use in a GlaxoSmithKline Phase IIb study.

Description

This will be a randomized, open-label, single-dose, five-period, crossover study in healthy volunteers to compare the relative bioavailability of 5 oral GSK1605786 formulations. Recruitment/screening will occur within approximately 30 days of the first scheduled dose of study medication. Each subject will participate in five dosing sessions - each dose will be separated by at least seven days. The total duration of a subject's participation in the study, from Screening to Follow-up, is approximately 10 weeks.

All subjects will receive single 500mg doses of the following five GSK1605786 formulations: A. ChemoCentryx formulation of GSK1605786; 2 x 250mg capsules [Formulation A] B. GSK formulation of GSK1605786; 2 x 250mg capsules [Formulation B] C. GSK direct-fill formulation of GSK1605786; 2 x 250mg capsules [Formulation C] D. GSK modified formulation of GSK1605786; 2 x 250mg capsules [Formulation D] E. GSK tablet formulation of GSK1605786; 500mg tablet [Formulation E]

Formulations A and B will administered in periods 1 and 2 in a random order, and formulations C, D and E will be administered in periods 3, 4, and 5 in a random order.

Subjects will check into the clinical research unit (CRU) 1 day prior to dosing (Day -1). The study medication will be administered in the morning of Day 1 with 240 mL of water 30 minutes after a standard breakfast (i.e., fed state). For each treatment period, subjects will stay in the CRU through the 48-hour PK sample on the morning of Day 3. Subjects may be released from the clinic on Day 3 (after all required study procedures are completed) and return to the CRU that evening and the next morning for collection of the 60- and 72-hour PK samples.

Upon completion of the last dosing period or early withdrawal, subjects will return to the clinic approximately seven days after the last dose of study medication for a follow up visit and be subsequently discharged from the study.

The study will be conducted at one center.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Conditions

Crohn's Disease

Intervention

GSK1605786 formulation B, GSK1605786 formulation E, GSK1605786 formulation D, GSK1605786 formulation C, GSK1605786 formulation A

Location

GSK Investigational Site
Buffalo
New York
United States
14202

Status

Completed

Source

GlaxoSmithKline

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:01-0400

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