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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00386347
First received: October 6, 2006
Last updated: May 31, 2012
Last verified: February 2011
History of Changes

October 6, 2006
May 31, 2012
October 2006
Not Provided
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
  • 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
Complete list of historical versions of study NCT00386347 on ClinicalTrials.gov Archive Site
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.
  • 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.
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A Study To Evaluate Formulations And Food Effect On GSK364735 In Healthy Subjects.
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.

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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • HIV Infection
  • Infection, Human Immunodeficiency Virus
Drug: GSK364735 oral solution and oral tablets
Other Name: GSK364735 oral solution and oral tablets
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
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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.
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00386347
GRZ108532
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP