NCT01101893

A Drug Interaction Study Evaluating GSK2248761 and Raltegravir Pharmacokinetics in Healthy Adult Subjects

A Phase I, Open Label, Single Sequence, Drug Interaction Study Evaluating Plasma GSK2248761 and Raltegravir Pharmacokinetics in Healthy Adult Subjects.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

In this study, approximately 16 subjects will receive raltegravir 400mg twice daily for 5 days (Treatment A) followed by a washout period. In Period 2, subjects will receive GSK2248761 200mg once daily for 5 days (Treatment B). There will be no wash out between Period 2 and 3. Subjects will then be administered raltegravir 400mg twice daily in combination with GSK2248761 200mg once daily (Treatment C) for 5 days. Subjects will be housed in the unit for the duration of the study. Safety evaluations and serial PK samples will be collected during each treatment period. A follow-up visit will occur 7-14 days after the last dose of study drug.

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

• Infection, Human Immunodeficiency Virus

Interventions

Type	Name	Description
DRUG	Raltegravir	raltegravir 400mg q12h x 5 days (Reference Treatment)
DRUG	GSK2248761	GSK2248761 200mg q24h x 5 days (Reference Treatment)
DRUG	GSK2248761 + Raltegravir	GSK2248761 200mg q24h + raltegravir 400mg q12h x 5 days (Test Treatment)

Timeline

• Start date: 2010-04-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2010-04-12
• Last updated: 2017-09-11

Locations

1 site across 1 country: United States