A Study To Evaluate Formulations And Food Effect On GSK364735 In Healthy Subjects.
This study has been completed.
Information provided by (Responsible Party):
First received: October 6, 2006
Last updated: May 31, 2012
Last verified: February 2011
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.
Infection, Human Immunodeficiency Virus
Drug: GSK364735 oral solution and oral tablets
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
||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.
Primary Outcome Measures:
- 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:
- 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.
| Estimated Enrollment:
| Study Start Date:
|Ages Eligible for Study:
||18 Years to 55 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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).
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00386347
|GSK Investigational Site
|Evansville, Indiana, United States, 47714 |
||GSK Clinical Trials
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 6, 2006
||May 31, 2012
||United States: Food and Drug Administration
Keywords provided by GlaxoSmithKline:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 10, 2014
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases