MedTrace Logo

First-in-Human Single and Multiple Dose of GLPG1837

NCT02325037 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2015-09-09

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 GLPG1837 given to healthy subjects, compared to placebo. Also, the safety and tolerability of multiple ascending oral doses of GLPG1837 given to healthy subjects daily for 14 days compared to placebo, will be evaluated.

Furthermore, during the course of the study after single and multiple oral dose administrations, the amount of GLPG1837 and its metabolite present in the blood and urine (pharmacokinetics) will be characterized.

The effect of food on the pharmacokinetics of GLPG1837 and its metabolite will also be evaluated.

The potential of cytochrome P450 (CYP)3A4 induction after repeated dosing with GLPG1837 will be explored as well.

Conditions

  • Healthy

Interventions

DRUG

GLPG1837 single ascending doses

Single dose, oral suspension

DRUG

Placebo single dose

Single dose, oral suspension matching placebo

DRUG

GLPG1837 multiple ascending doses

Multiple 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

  • Frédéric Vanhoutte, MD · Galapagos NV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • Belgium

Study Locations

More Related Trials

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 NCT02325037 on ClinicalTrials.gov