A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Repeat Doses of GSK2586184 and the Effect of Food and Gender
NCT01687309 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19
Last updated 2018-05-25
Summary
A study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and repeat doses of 800 mg GSK2586184 in healthy subjects.
Conditions
Interventions
- DRUG
-
GSK2586184 800mg single and repeat dose
GSK2586184 800mg single dose and then twice daily dosing for 13 days
- DRUG
-
Placebo-to-match GSK2586184
Placebo-to-match GSK2586184
- OTHER
-
GSK2586184 single dose taken with food
GSK2586184 single dose taken with FDA approved high fat, high calorie breakfast
- OTHER
-
GSK2586184 single dose taken without food
GSK2586184 single dose taken in a fasted state
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
GSK Clinical Trials · GlaxoSmithKline
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2012-04-30
- Primary Completion
- 2012-07-31
- Completion
- 2012-07-31
Countries
- Belgium
Study Locations
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