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GSK1349572 Proton Pump Inhibitor Drug Interaction and Supratherapeutic Dose Study

NCT00942136 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2009-10-09

No results posted yet for this study

Summary

GSK1349572 is an integrase inhibitor that is currently being evaluated for the treatment of HIV infection. The primary objective of this study is to determine whether the addition of a proton pump inhibitor, omeprazole, to GSK1349572 impacts the blood levels of GSK1349572. It will also evaluate if a high fat meal impacts the blood levels of GSK1349572. In addition, the safety, tolerability, and pharmacokinetics of single supratherapeutic (high) dose of GSK1349572 will be evaluated.

Conditions

  • Healthy Volunteer

Interventions

DRUG

GSK1349572

GSK1349572 250 mg suspension as a single dose. GSK1349572 is an investigational (not approved by the FDA) medication for the treatment of HIV in the class of integrase inhibitors.

DRUG

GSK1349572

GSK1349572 50 mg tablets as a single dose on three separate occasions. GSK1349572 is an investigational (not approved by the FDA) medication for the treatment of HIV in the class of integrase inhibitors.

DRUG

Placebo

Placebo Suspension as a single dose.

DRUG

Omeprazole

Omeprazole 40 mg once a day for 5 days. Omeprazole is approved by the FDA currently to reduce stomach acid, treat stomach ulcers, and gastroesophageal reflux disease.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2009-09-30
Completion
2009-09-30

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT00942136 on ClinicalTrials.gov