Oral Bioavailability of Two Solid Formulations of GLPG0634

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01915667
• Other study ID #: GLPG0634-CL-107
• Status: Completed
• Phase: Phase 1
• First received: August 2, 2013
• Last updated: September 16, 2013
• Start date: July 2013
• Est. completion date: September 2013

Study information

• Verified date: September 2013
• Source: Galapagos NV
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• 200 mg GLPG0634 as capsules, fasted
single oral dose of 200 mg GLPG0634 given as capsules in fasted condition
• 200 mg GLPG0634 as tablets, fasted
single oral dose of 200 mg GLPG0634 given as tablets in fasted condition
• 200 mg GLPG0634 as tablets, fed
single oral dose of 200 mg GLPG0634 given as tablets in fed condition

Locations

Country	Name	City	State
Belgium	SGS LSS Clinical Pharmacology Unit Antwerp	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
Galapagos NV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	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	Yes