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

HIV Infection Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00386347
• Other study ID #: GRZ108532
• Status: Completed
• Phase: Phase 1
• First received: October 6, 2006
• Last updated: May 31, 2012
• Start date: October 2006

Study information

• Verified date: February 2011
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infection
• HIV Infections
• Immunologic Deficiency Syndromes
• Infection
• Infection, Human Immunodeficiency Virus

Intervention

Drug:
• GSK364735 oral solution and oral tablets

Locations

Country	Name	City	State
United States	GSK Investigational Site	Evansville	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.