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
  Purpose

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.


Condition Intervention Phase
HIV Infection
Infection, Human Immunodeficiency Virus
Drug: GSK364735 oral solution and oral tablets
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

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: 56
Study Start Date: October 2006
Intervention Details:
    Drug: GSK364735 oral solution and oral tablets
    Other Name: GSK364735 oral solution and oral tablets
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00386347

Locations
United States, Indiana
GSK Investigational Site
Evansville, Indiana, United States, 47714
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00386347     History of Changes
Other Study ID Numbers: GRZ108532
Study First Received: October 6, 2006
Last Updated: May 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
HIV
repeat dose
pharmacokinetics
bioavailability
single-dose
food effect

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Communicable Diseases
HIV Infections
Immunologic Deficiency Syndromes
Infection
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014