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

Completed · Phase 1

Conditions studied: HIV Infection, Infection, Human Immunodeficiency Virus

In brief

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.

Key facts

Study ID

NCT00386347

Run by

GlaxoSmithKline

People needed

56

Starts

2006-10-01

Last updated by the study team

2012-06-04

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Evansville, Indiana, United States

Full record on ClinicalTrials.gov

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