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A Randomized Study to Assess the Relative Bioavailability of New Formulations of GSK1265744 Long Acting Parental (LAP) in Healthy Adult Subjects

NCT01754116 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2014-04-21

No results posted yet for this study

Summary

This is a single-center, randomized, open-label, 3 parallel treatment study in healthy adult subjects to assess the relative bioavailability of new formulations of GSK1265744 LAP 400 mg intra muscular compared to the current GSK1265744 LAP 400 mg nanomilled formulation. This study will evaluate LAP formulations of GSK1265744 with different particle sizes.

Following a 14 day lead in period with oral GSK1265744, forty-five subjects will receive 400 mg of one of three GSK1265744 formulations which vary in particle size from 200 nm to 5 um by intramuscular injection. Samples for determination of GSK1265744 concentrations will be collected for 12 weeks post-injection. Safety will be evaluated by adverse event recording and laboratory values at frequent intervals throughout the trial. A subgroup of 12 subjects will receive a 3 mg dose of oral midazolam at baseline on Day-29 and then again on the last day of the oral GSK1265744 lead in period to evaluate the effect of GSK1265744 on CYP3A enzymes.

The subjects will undergo follow-up evaluations for a minimum of 12 weeks.

Conditions

  • Infection, Human Immunodeficiency Virus

Interventions

DRUG

GSK1265744 30 mg oral

GSK1265744B 30 mg Tablet taken orally, once a day in the morning with or without a meal

DRUG

Midazolam 3 mg oral + GSK1265744 30mg oral

Midazolam Syrup 3mg each mL Oral/single dose administer by oral syringe on Day -29 and Day -14

DRUG

GSK1265744 400 mg (200 nm)

A single dose of GSK1265744 400 mg Intra Muscular (IM) injection (Nanomilled 200 nm)

DRUG

GSK1265744 400 mg (1 micro m)

A single dose of GSK1265744 400 mg IM injection (Nanomilled 1 micrometer)

DRUG

GSK1265744 400 mg (5 micro m)

A single dose of GSK1265744 400 mg IM injection (Dry milling and homogenization 5 micrometer)

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · ViiV Healthcare

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
2013-01-31
Primary Completion
2014-04-30
Completion
2014-04-30

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 NCT01754116 on ClinicalTrials.gov