NCT00386347CompletedPhase 1
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.
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 56
- Locations
- 2
- Primary Endpoint
- 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
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
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 Outcomes
- 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.
Investigators
Study Sites (2)
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