Skip to main content
OpenTrials
Completed

NCT Number: NCT01915667

Oral Bioavailability of Two Solid Formulations of GLPG0634

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

40 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

SGS LSS Clinical Pharmacology Unit Antwerp

Antwerp, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

200 mg GLPG0634 as capsules, fasted

Drug

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

200 mg GLPG0634 as tablets, fasted

Drug

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

200 mg GLPG0634 as tablets, fed

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Lakefront Biotherapeutics NV

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Aug 5, 2013
Registry last updated
Sep 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.