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Oral Bioavailability of Two Solid Formulations of GLPG0634

NCT01915667 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2013-09-17

No results posted yet for this study

Summary

The purpose of the study is to evaluate the amount of compound present in the blood (relative bioavailability) after a single administration of GLPG0634 as a tablet versus a capsule in fasted conditions in male healthy subjects.

Also, the effect of food on the bioavailability of the tablet formulation will be studied as well as the safety and tolerability of single oral doses of GLPG0634 given either as capsule or tablet.

Conditions

  • Healthy

Interventions

DRUG

200 mg GLPG0634 as capsules, fasted

single oral dose of 200 mg GLPG0634 given as capsules in fasted condition

DRUG

200 mg GLPG0634 as tablets, fasted

single oral dose of 200 mg GLPG0634 given as tablets in fasted condition

DRUG

200 mg GLPG0634 as tablets, fed

single oral dose of 200 mg GLPG0634 given as tablets in fed condition

Sponsors & Collaborators

  • Galapagos NV

    lead INDUSTRY

Principal Investigators

  • Pille Harrison, MD · Galapagos NV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2013-09-30
Completion
2013-09-30

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 NCT01915667 on ClinicalTrials.gov