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Completed Phase 1 Interventional Accepts healthy volunteers

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

ClinicalTrials.gov ID: NCT01101893

Public ClinicalTrials.gov record NCT01101893. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 9, 2026, 8:45 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01101893
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
ViiV Healthcare
Industry
Enrollment
15 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 50 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 31, 2010
Primary completion
May 31, 2010
Completion
May 31, 2010
Last update posted
Sep 10, 2017

2010

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
GSK Investigational Site Buffalo New York 14202

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

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About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01101893, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 10, 2017 · Synced Sep 9, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01101893 live on ClinicalTrials.gov.

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