A Study to Assess Safety, Tolerability and Pharmacokinetics of GLPG2737 in Healthy Subjects
NCT03410979 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 79
Last updated 2018-01-25
Summary
This study is a first-in-human (FIH), Phase I, single center, randomized, double-blind, placebo-controlled, sequential group study in healthy male subjects to assess the safety, tolerability and PK of single ascending oral doses of GLPG2737 and multiple ascending oral doses of GLPG2737 administered for 14 days.
Conditions
- Healthy
Interventions
- DRUG
-
GLPG2737 single dose
GLPG2737 oral suspension, single ascending doses
- DRUG
-
Placebo single dose
Placebo, oral suspension.
- DRUG
-
GLPG2737 multiple dose
GLPG2737 oral suspension, multiple ascending doses, daily for 14 days.
- DRUG
-
GLPG2737 multiple dose
Placebo, oral suspension, daily for 14 days
Sponsors & Collaborators
-
Galapagos NV
lead INDUSTRY
Principal Investigators
-
Chris Brearley, BM, MRCP, MFPM · Galapagos NV
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- QUADRUPLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2016-11-25
- Primary Completion
- 2017-08-15
- Completion
- 2017-08-15
Countries
- Netherlands
Study Locations
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