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

NCT01209117 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-06-08

No results posted yet for this study

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).

Conditions

  • Infections, Human Immunodeficiency Virus and Herpesviridae
  • Infection, Human Immunodeficiency Virus

Interventions

DRUG

GSK2248761 WBM Capsule

200 mg GSK2248761 WBM capsule (reference) 2 X100mg

DRUG

GSK2248761 WBM Tablet Formulation 1

GSK2248761 WBM Tablet 200mg manufacturing process 1

DRUG

GSK2248761 WBM Tablet Formulation 2

GSK2248761 WBM Tablet 200mg manufacturing process 2

DRUG

GSK2248761 WBM Tablet Formulation 3

GSK2248761 WBM Tablet 200mg manufacturing process 3

DRUG

GSK2248761 WBM Tablet

GSK2248761 WBM tablet 200mg manufacturing process 1, 2, or 3 chosen from Period 1 - 4

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · ViiV Healthcare

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT01209117 on ClinicalTrials.gov