Last updated: 11/04/2018 07:59:47

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

GSK study ID
GRZ108532
Clinicaltrials.gov ID
NCT00386347
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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.
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: GSK364735 oral solution and oral tablets
Enrollment:
56
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
HIV Infection
Product
GSK364735
Collaborators
Not applicable
Study date(s)
October 2006 to February 2007
Type
Interventional
Phase
1

Participation criteria

Sex
Female & Male
Age
18 - 55 years
Accepts healthy volunteers
Yes
  • 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.
  • 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
Inclusion and exclusion 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.

Trial location(s)

Location
Status
Contact us
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Location
GSK Investigational Site
Evansville, Indiana, United States, 47714
Status
Study Complete
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Study documents

No study documents available.

Results overview

Study Results yet to be posted

Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2007-23-02

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Additional information
Not applicable
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