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A Study to Evaluate the Effects of a Single and Multiple Oral Doses of GLPG3121 in Adult, Healthy, Male Subjects

NCT03899909 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2019-07-05

No results posted yet for this study

Summary

This study is a first-in-human, Phase I, randomized, double-blind, placebo controlled, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of GLPG3121 after oral single ascending doses (SAD) of GLPG3121 (part 1) and after oral multiple ascending doses (MAD) for 13 days of GLPG3121 (part 2) in healthy male subjects.

Conditions

  • Healthy

Interventions

DRUG

GLPG3121 SAD

GLPG3121 oral suspension, single ascending doses

DRUG

Placebo SAD

Placebo oral suspension

DRUG

GLPG3121 MAD

GLPG3121 oral suspension, multiple ascending doses, daily for 13 days

DRUG

Placebo MAD

Placebo oral suspension, daily for 13 days

Sponsors & Collaborators

  • Galapagos NV

    lead INDUSTRY

Principal Investigators

  • Magdalena Petkova, MD · Galapagos NV

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2019-03-29
Primary Completion
2019-06-03
Completion
2019-06-03

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 NCT03899909 on ClinicalTrials.gov