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A Study to Evaluate the Effects of Single and Multiple Oral Doses of GLPG3667

NCT04097938 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2024-09-19

No results posted yet for this study

Summary

This study is a first-in-human, Phase I, randomized, double-blind, placebo-controlled, single-center, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of GLPG3667 after oral single ascending doses (SAD) of GLPG3667 (part 1) and after oral multiple ascending doses (MAD) for 13 days of GLPG3667 (part 2) in healthy male subjects. In addition, the effect of food (FE) on safety, tolerability, and PK of GLPG3667 oral suspension will be evaluated (part 3 - will not be completed), and the relative bioavailability (rBA) of the capsule versus the oral suspension with the effect of food on the bioavailability of the capsule (part 4), both part 3 and 4 using an open-label, randomized, crossover design.

Conditions

  • Healthy

Interventions

DRUG

GLPG3667 oral suspension

GLPG3667 oral suspension

DRUG

Placebos

Placebo oral suspension

DRUG

GLPG3667 capsules

GLPG3667 capsules

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
2019-09-18
Primary Completion
2020-03-04
Completion
2020-07-06

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 NCT04097938 on ClinicalTrials.gov