Back to resultsA Study To Evaluate Formulations And Food Effect On GSK364735 In Healthy Subjects.
Primary Purpose
HIV Infection, Infection, Human Immunodeficiency Virus
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
GSK364735 oral solution and oral tablets
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infection focused on measuring HIV, repeat dose, pharmacokinetics, bioavailability, single-dose, food effect
Eligibility 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.
Sites / Locations
- GSK Investigational Site
Outcomes
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00386347
Brief Title
A Study To Evaluate Formulations And Food Effect On GSK364735 In Healthy Subjects.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infection, Infection, Human Immunodeficiency Virus
Keywords
HIV, repeat dose, pharmacokinetics, bioavailability, single-dose, food effect
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
56 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
GSK364735 oral solution and oral tablets
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study To Evaluate Formulations And Food Effect On GSK364735 In Healthy Subjects.
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