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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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HIV Infection, Infection, Human Immunodeficiency Virus

Intervention / Treatment
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* Drug: GSK364735 oral solution and oral tablets


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: GSK364735 oral solution and oral tablets|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, repeat dose, pharmacokinetics, bioavailability, single-dose, food effect