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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

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.

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Detailed Description

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Conditions

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HIV Infection Infection, Human Immunodeficiency Virus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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GSK364735 oral solution and oral tablets

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes