MedTrace Logo

A Study in Healthy Volunteers to Compare Different Tablet Formulations of the Test Medicine, GLPG1972, Against the Current Tablet Formulation, and to Assess the Effect Food Has on One of the Test Medicines

NCT04137341 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2020-01-13

No results posted yet for this study

Summary

The sponsor wants to investigate two new tablet formulations (recipes) of the test medicine, and how they are taken up by the body in comparison to the current tablet formulation (study periods 1 to 3). If one of the 2 new tablets has a more favourable profile than the current tablet in periods 1 to 3, the sponsor will then investigate the effect that food has on this new tablet in study period 4. However, if the new tablets do not have a more favourable profile than the current tablet, the food effect does not need to be investigated and study period 4 will not be needed.

Conditions

  • Healthy

Interventions

DRUG

GLPG1972 - A

Film-coated tablet, formulation A

DRUG

GLPG1972 - B

Film-coated tablet, formulation B

DRUG

GLPG1972 - C

Film-coated tablet, formulation C

Sponsors & Collaborators

  • Galapagos NV

    lead INDUSTRY

Principal Investigators

  • Angela de Haas-Amatsaleh, MD · Galapagos NV

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2019-10-09
Primary Completion
2019-12-13
Completion
2019-12-13

Countries

  • United Kingdom

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 NCT04137341 on ClinicalTrials.gov