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GSK1349572 Relative Bioavailability Study

NCT01098513 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-06-09

No results posted yet for this study

Summary

This is a single-center, randomized, two part, open-label, crossover study in healthy adult subjects. Part A will evaluate the relative bioavailability of two new tablet formulations compared to the current tablet formulation of GSK1349572 at 50 mg administered as single doses each comprising of two 25 mg tablets. Pharmacokinetic samples from Part A will be analyzed and, if at least one of the new formulations meets appropriate criteria and is selected, Part B will be a single-sequence design conducted to evaluate food effect of the selected new tablet formulation at one dose level. A subset of subjects enrolled in Part A will continue in Part B. Safety evaluations and serial PK samples will be collected during each treatment period. A follow-up visit will occur 7-28 days after the last dose of study drug.

Conditions

  • Infection, Human Immunodeficiency Virus

Interventions

DRUG

GSK1349572 formulation AP

GSK1349572 50 mg single dose fasted.

DRUG

GSK1349572 formulation AW

GSK1349572 formulation AW 50 mg single dose in Part A and 75 to 200 mg fasted or with moderate or high fat meal in Part B.

DRUG

GSK1349572 formulation AX

GSK1349572 formulation AX 50 mg in Part A and 75-200 mg fasted or with a moderate or high fat meal in Part B

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2010-06-30
Completion
2010-07-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT01098513 on ClinicalTrials.gov