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A Drug Interaction Study Evaluating Plasma GSK2248761 and GSK1349572 Pharmacokinetics in Healthy Adult Subjects.

2014-08-27 04:00:23 | BioPortfolio

Summary

This is a single-center, open-label, three-period, fixed-sequence cross over study in healthy adult subjects. A total of approximately 16 healthy subjects will be enrolled to provide data from 12 evaluable subjects. Subjects will have a screening visit within 30 days prior to the first dose of study drug, three treatment periods, and a follow-up visit 7-14 days after the last dose of study drug. There will be a washout period between Period 1 and Period 2 but no washout between Period 2 and Period 3. Day 1 of Period 3 will be the day after Day 5 of Period 2.

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Conditions

Human Immunodeficiency Virus I Infection

Intervention

GSK1349572, GSK2248761

Location

GSK Investigational Site
Buffalo
New York
United States
14202

Status

Suspended

Source

GlaxoSmithKline

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T04:00:23-0400

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Medical and Biotech [MESH] Definitions

Proteins encoded by the VPR GENES of the HUMAN IMMUNODEFICIENCY VIRUS.

Proteins encoded by the NEF GENES of the HUMAN IMMUNODEFICIENCY VIRUS.

Proteins encoded by the VIF GENES of the HUMAN IMMUNODEFICIENCY VIRUS.

Proteins encoded by the TAT GENES of the HUMAN IMMUNODEFICIENCY VIRUS.

Proteins encoded by the REV GENES of the HUMAN IMMUNODEFICIENCY VIRUS.

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