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First-in-Human Single and Multiple Dose of GLPG1690

NCT02179502 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2015-09-22

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 GLPG1690 given to healthy male subjects, compared to placebo. Also, the safety and tolerability of multiple ascending oral doses of GLPG1690 given to healthy male 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 GLPG1690 present in the blood and urine (pharmacokinetics) as well as the reduction of biomarker levels by GLPG1690 in plasma samples (pharmacodynamics) will be characterized compared to placebo.

The pharmacokinetics of a solid dosage formulation of GLPG1690 will be compared with those of a liquid dosage formulation of GLPG1690.

Also, the potential of cytochrome P450 (CYP)3A4 induction after repeated dosing with GLPG1690 will be explored.

Conditions

  • Healthy

Interventions

DRUG

GLPG1690 single ascending doses

Single dose, oral suspension or solid formulation, starting dose of 20mg escalating up to 1500mg

DRUG

Placebo single ascending doses

Single dose, oral suspension or solid formulation matching placebo

DRUG

GLPG1690, multiple ascending doses, oral suspension

Multiple doses, daily for 14 days, oral suspension, anticipated doses: 300mg to 1000mg

DRUG

Placebo, multiple ascending doses, oral suspension

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
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2014-11-30
Completion
2014-12-31

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 NCT02179502 on ClinicalTrials.gov