Oral Bioavailability of Two Solid Formulations of GLPG0634

September 16, 2013 updated by: Galapagos NV

Bioavailability Study Comparing Two Solid Oral Formulations of GLPG0634 in Healthy Male Subjects

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerp, Belgium
        • SGS LSS Clinical Pharmacology Unit Antwerp

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy male, age 40-60 years
  • BMI between 18-30 kg/m2

Exclusion Criteria:

  • Any condition that might interfere with the procedures or tests in this study
  • Drug or alcohol abuse
  • Smoking

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GLPG0634 capsule fasted
Single dose of GLPG0634 as capsules in fasted condition
Drug: 200 mg GLPG0634 as capsules, fasted
single oral dose of 200 mg GLPG0634 given as capsules in fasted condition
Experimental: GLPG0634 tablet fasted
Single dose of GLPG0634 as tablets in fasted condition
Drug: 200 mg GLPG0634 as tablets, fasted
single oral dose of 200 mg GLPG0634 given as tablets in fasted condition
Active Comparator: GLPG0634 tablet fed
Single dose of GLPG0634 as tablets in fed condition
Drug: 200 mg GLPG0634 as tablets, fed
single oral dose of 200 mg GLPG0634 given as tablets in fed condition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The amount of GLPG0634 and metabolite in plasma after a single dose of GLPG0634 as capsules or tablets
Time Frame: From predose (before first study drug administration) up to 144 hours post last study drug administration
To characterize and compare the amount of GLPG0634 and metabolite in plasma (relative bioavailability) in male healthy subjects after a single administration of either a capsule or tablet formulation in a fasted condition. For the tablet formulation, also the amount of GLPG0634 and metabolite in plasma will be evaluated after fasting and in fed condition.
From predose (before first study drug administration) up to 144 hours post last study drug administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of subjects with adverse events, abnormal lab tests, physical examinations, vital signs and ECG after a single dose of GLPG0634 as capsules or tablets
Time Frame: Between screening and 7-10 days after the last dose
To evaluate the safety and tolerability of GLPG0634 after a single oral dose as capsules or tablets, either fasted or fed, in male healthy subjects in terms of adverse events (AEs), abnormalities in laboratory tests, physical examinations, vital signs and electrocardiogram (ECG)
Between screening and 7-10 days after the last dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galapagos NV

Investigators

  • Study Director: Pille Harrison, MD, Galapagos NV

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

August 2, 2013

First Submitted That Met QC Criteria

August 2, 2013

First Posted (Estimate)

August 5, 2013

Study Record Updates

Last Update Posted (Estimate)

September 17, 2013

Last Update Submitted That Met QC Criteria

September 16, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • GLPG0634-CL-107

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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