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Relative Bioavailability Study of GSK1265744 Formulations

NCT01648257 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2016-08-12

No results posted yet for this study

Summary

This is a single-center, randomized, open-label, balanced, 3 way crossover study (3 periods) in healthy adult subjects. During each period, subjects will receive a single dose of GSK1265744 oral formulation in the fasted state and serial PK sampling for up to 168 hours (8 days) and safety assessments will be performed. Each period will be separated by a washout period of at least 14 days and a follow-up visit will occur 10 to 14 days after the last dose of study drug.

Conditions

  • Infections, Human Immunodeficiency Virus and Hepatitis

Interventions

DRUG

GSK1265744 Na Salt Tablets

Each tablet contains 30 mg of GSK1265744 sodium salt and excipients.

DRUG

GSK1265744 Free Acid Nanomilled Capsules

Each capsule contains 30 mg of nanomilled and spray dried GSK1265744 free acid, blended with excipients.

DRUG

GSK1265744 Free Acid Micronized Capsules

Each capsule contains 30 mg of micronized GSK1265744 free acid, blended with excipients.

Sponsors & Collaborators

  • ViiV Healthcare

    lead INDUSTRY

Principal Investigators

  • GSK Clinical Trials · ViiV Healthcare

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • United States

Study Locations

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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 NCT01648257 on ClinicalTrials.gov