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A Study to Evaluate How Well Single and Multiple Doses of GLPG4399 Are Tolerated in Healthy, Adult Subjects

NCT04653467 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2022-02-01

No results posted yet for this study

Summary

The main purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single (part 1) and multiple ascending (part 2) oral doses of GLPG4399, in adult, healthy, male subjects. In addition, the effect of food and the relative bioavailability (rBA) of GLPG4399, will be evaluated (part 3 and 4).

Conditions

  • Healthy

Interventions

DRUG

GLPG4399 oral suspension

GLPG4399 for oral administration

DRUG

GLPG4399 capsules

GLPG4399 for oral administration

DRUG

Placebo

Placebo oral suspension

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
54 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-06
Primary Completion
2022-01-10
Completion
2022-01-10

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

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 NCT04653467 on ClinicalTrials.gov