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

GlaxoSmithKline56 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

HIV Infection Infection, Human Immunodeficiency Virus

Interventions

GSK364735 oral solution and oral tabletsDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

GSK Investigational Site

Evansville, Indiana, United States

Outcomes

Primary Outcomes

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 Outcomes

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.

Data from ClinicalTrials.gov

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