Clinical Trials Directory

Trials / Completed

CompletedNCT01209117

A Study to Assess the Relative Bioavailability of Tablet Formulations of GSK2248761 in Healthy Adult Subjects. SGN114435

A Single-center, Randomized, Open-label, Crossover Study to Assess the Relative Bioavailability of Tablet Formulations of GSK2248761 in Healthy Adult Subjects. SGN114435

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
24 (actual)
Sponsor
ViiV Healthcare · Industry
Sex
All
Age
18 Years – 50 Years
Healthy volunteers
Accepted

Summary

This is a single-center, randomized, two part, open-label, crossover study in healthy adult subjects to assess the oral bioavailability of three GSK2248761 Wet Bead Milled (WBM) tablet formulations manufactured by three different processes relative to the GSK2248761 WBM capsule formulation (Part A) and the effect of a moderate-fat meal on the bioavailability of the selected WBM tablet formulation (Part B).

Detailed description

ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship

Conditions

Interventions

TypeNameDescription
DRUGGSK2248761 WBM Capsule200 mg GSK2248761 WBM capsule (reference) 2 X100mg
DRUGGSK2248761 WBM Tablet Formulation 1GSK2248761 WBM Tablet 200mg manufacturing process 1
DRUGGSK2248761 WBM Tablet Formulation 2GSK2248761 WBM Tablet 200mg manufacturing process 2
DRUGGSK2248761 WBM Tablet Formulation 3GSK2248761 WBM Tablet 200mg manufacturing process 3
DRUGGSK2248761 WBM TabletGSK2248761 WBM tablet 200mg manufacturing process 1, 2, or 3 chosen from Period 1 - 4

Timeline

Start date
2010-09-01
Primary completion
2011-01-01
Completion
2011-01-01
First posted
2010-09-27
Last updated
2017-06-08

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01209117. Inclusion in this directory is not an endorsement.