A Study To Evaluate Formulations And Food Effect On GSK364735 In Healthy Subjects.

A Single Dose, Randomized, 5-Period, Balanced, Crossover Study to Assess the Relative Bioavailability of Three Formulations and Food Effect on GSK364735 and Pharmacokinetics Following a Double Blind, Placebo Controlled, Repeat Dose Administration to Healthy Subjects.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00386347

Enrollment

Registered

2006-10-11

Start date

2006-10-31

Completion date

Unknown

Last updated

2012-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infection, Infection, Human Immunodeficiency Virus

Keywords

HIV, repeat dose, pharmacokinetics, bioavailability, single-dose, food effect

Brief summary

This study is a two-part study. Part one is designed to see how different formulations of GSK364735 are absorbed in the body and To see how food affects how GSK364735 is absorbed in the body. Part two is designed to see how repeat dosing affects how GSK364735 is absorbed in the body.

Interventions

DRUGGSK364735 oral solution and oral tablets

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* The subject is healthy with no clinically significant problems identified by the physician. * Females of non-childbearing potential and males surgically sterile or agrees to birth control. * Body mass Index (BMI) of 19-29.9 (kg/m2).

Exclusion criteria

* As a result of the physical examination, lab results the Investigator considers the subject unfit for the study. * Blood pressure and electrocardiogram is not normal * A history of alcohol or illicit drug abuse. * Tobacco use within 3 months. * Positive for Hepatitis B surface antigen, Hepatitis C antibody or HIV antibody. * Current use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements. * Has participated in a clinical trial within 30 days prior to the first dose of study medication. * Donated a pint of blood within a 56 day period. * History of allergy to study drug.

Design outcomes

Primary

Measure	Time frame
Part 1: PK parameters Day 1: AUC(0-t), AUC(0-t), Cmax, and C12 and C24 Part 2: PK parameters on Day 6: AUC(0-t), Ct, and Cmax	—

Secondary

Measure	Time frame
Part 1 and 2 safety measures: AE, Clinical labs, con meds, ECGs, and Vital signs Part 1: PK parameters Day 1: tmax, t1/2, tlag and CL/F Part 2: PK parameters Day 1&6: AUC 0-t, AUC 0-infinity, AUC 0-12, Cmax, C12 or C24, tmax, t1/2, CL/F, and tlag.	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026