Oral Bioavailability of Two Solid Formulations of GLPG0634

NCT01915667 | Completed Phase 1

• 1 other identifier: GLPG0634-CL-107
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• The amount of GLPG0634 and metabolite in plasma after a single dose of GLPG0634 as capsules or tablets

  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 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

  Between screening and 7-10 days after the last dose

Study Arms (3)

GLPG0634 capsule fasted

EXPERIMENTAL

Single dose of GLPG0634 as capsules in fasted condition

Drug: 200 mg GLPG0634 as capsules, fasted

GLPG0634 tablet fasted

EXPERIMENTAL

Single dose of GLPG0634 as tablets in fasted condition

Drug: 200 mg GLPG0634 as tablets, fasted

GLPG0634 tablet fed

ACTIVE COMPARATOR

Single dose of GLPG0634 as tablets in fed condition

Drug: 200 mg GLPG0634 as tablets, fed

Interventions

200 mg GLPG0634 as capsules, fasted DRUG

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

GLPG0634 capsule fasted

200 mg GLPG0634 as tablets, fasted DRUG

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

GLPG0634 tablet fasted

200 mg GLPG0634 as tablets, fed DRUG

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

GLPG0634 tablet fed

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Galapagos NV: lead

Study Sites (1)

SGS LSS Clinical Pharmacology Unit Antwerp

Antwerp, Antwerp, Belgium

Location

MeSH Terms

Interventions

GLPG0634; Capsules; Tablets

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Pille Harrison, MD

  Galapagos NV

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2013
• First Posted: August 5, 2013
• Study Start: July 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: September 17, 2013

Record last verified: 2013-09

Locations

BE (1)