A Study to Assess Safety, Tolerability and Pharmacokinetics of GLPG2451 in Healthy Male Subjects
NCT03214614 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 39
Last updated 2017-09-13
Summary
The study is a Phase I, randomized, double-blind, placebo-controlled study evaluating multiple ascending oral doses of GLPG2451 and the combination of GLPG2451 and GLPG2222 given for 14 days in healthy male subjects.
The purpose of the study is to evaluate the safety and tolerability of multiple ascending oral doses of GLPG2451 given to healthy male subjects compared to placebo, as well as of multiple oral doses of the combination of GLPG2451/GLPG2222 compared to placebo.
Conditions
- Healthy
Interventions
- DRUG
-
GLPG2451 multiple dose
GLPG2451 oral suspension, multiple ascending doses, daily for 14 days
- DRUG
-
Placebo multiple dose
Placebo, oral suspension, daily for 14 days
- DRUG
-
GLPG2451/GLPG2222 multiple dose
GLPG2451 oral suspension and GLPG2222 oral suspension, multiple doses, daily for 14 days
- DRUG
-
Combined Placebo multiple dose
Combined Placebo, oral suspension, daily for 14 days
Sponsors & Collaborators
-
Galapagos NV
lead INDUSTRY
Principal Investigators
-
Chris Brearley, MD · Galapagos NV
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2016-11-14
- Primary Completion
- 2017-08-25
- Completion
- 2017-08-25
Countries
- Belgium
Study Locations
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