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First-in-Human Single and Multiple Dose of GLPG2222

NCT02662452 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-07-29

No results posted yet for this study

Summary

The purpose of this First-in-Human study is to evaluate the safety and tolerability after single ascending oral doses of GLPG2222 given to healthy subjects, compared to placebo (Part 1). Also, the safety and tolerability of multiple ascending oral doses of GLPG2222 given to healthy subjects daily for 14 days compared to placebo, will be evaluated (Part 2).

Furthermore, during the course of the study after single and multiple oral dose administrations, the amount of GLPG2222 present in the blood and urine (pharmacokinetics) will be characterized.

The potential of cytochrome P450 (CYP)3A4 interaction after repeated dosing with GLPG2222 will be explored as well.

Conditions

  • Healthy

Interventions

DRUG

GLPG2222 single dose

single ascending doses, oral suspension

DRUG

Placebo single dose

single doses, oral suspension, matching placebo

DRUG

GLPG2222 multiple doses

multiple ascending doses, daily for 14 days, oral suspension

DRUG

Placebo multiple doses

multiple doses, daily for 14 days, oral suspension, matching placebo

Sponsors & Collaborators

  • Galapagos NV

    lead INDUSTRY

Principal Investigators

  • Kirsteen Donaldson, MD · Galapagos NV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2016-04-30
Completion
2016-05-31

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 NCT02662452 on ClinicalTrials.gov