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A Study Investigating the Safety, Absorption and Elimination of GLPG3312, a New Drug in the Treatment of Inflammatory Diseases

NCT03800472 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2020-03-19

No results posted yet for this study

Summary

The purpose of this study is to investigate how safe 2 different formulations (immediate-release (IR) and modified-release (MR) tablets) of the new compound GLPG3312 are and how well they are tolerated when they are administered to healthy volunteers. Immediate-release and modified-release tablets contain the same active ingredient, but the modified-release tablet is covered with a protective layer, so it will dissolve in the intestines and not in the stomach. GLPG3312 has not been administered to humans before. Next to assessing the safety and tolerability, the purpose of this study is to investigate how food affects how quickly and to what extent GLPG3312 in a modified release formulation is absorbed and eliminated from the body. In addition, the effect of GLPG3312 on the body will be investigated by evaluating the effect of GLPG3312 on markers of the immune response.

Conditions

  • Healthy

Interventions

DRUG

GLPG3312 IR

GLPG3312 IR tablets, up to 4 single ascending oral doses (A, B, C, D).

DRUG

Placebo

Placebo tablets

DRUG

GLPG3312 MR

GLPG3312 MR film-coated tablets, up to 4 single ascending oral doses (H, I, J, K).

DRUG

GLPG3312 FE MR

GLPG3312 MR film-coated tablets, single oral dose (N) on 2 occasions, i.e. in fed state after a high-fat high-calorie breakfast, and in fasted state.

DRUG

GLPG3312 MR

GLPG3312 MR film-coated tablets, up to 2 multiple ascending oral doses (O, P).

DRUG

GLPG3312 MR

GLPG3312 MR optimized film-coated tablets, up to 3 multiple ascending oral doses (Q, R, S).

DRUG

Placebo

Placebo optimized tablets

Sponsors & Collaborators

  • Galapagos NV

    lead INDUSTRY

Principal Investigators

  • Magdalena Petkova, MD · Galapagos NV

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-01-15
Primary Completion
2020-03-10
Completion
2020-03-10

Countries

  • Netherlands

Study Locations

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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 NCT03800472 on ClinicalTrials.gov