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

NCT01283100 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2014-12-24

No results posted yet for this study

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.

Conditions

  • Infection, Human Immunodeficiency Virus I

Interventions

DRUG

GSK1349572

50mg once every 24 hours for 7 days

DRUG

GSK2248761

200 mg once every 24 hours for 7 days

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · ViiV Healthcare

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2011-03-31
Completion
2011-06-30

Countries

  • United States

Study Locations

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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 NCT01283100 on ClinicalTrials.gov