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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03214614 on ClinicalTrials.gov