Oral Bioavailability of Solid Formulation of GLPG1205 With and Without Food

Healthy Clinical Trial

Official title:

A Randomized, Open-label, Two-way Cross-over Study to Determine the Oral Bioavailability of GLPG1205 After Single-dose Intake in Healthy Male Subjects as a Solid Formulation, With and Without Food

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02143856
• Other study ID #: GLPG1205-CL-102
• Secondary ID: 2013-004771-12
• Status: Completed
• Phase: Phase 1
• First received: May 18, 2014
• Last updated: July 21, 2014
• Start date: May 2014
• Est. completion date: July 2014

Study information

• Verified date: July 2014
• 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 oral administration of GLPG1205 given as a capsule formulation in fasted versus fed conditions in male healthy subjects.

Also, the safety and tolerability of a single oral dose of GLPG1205 given as a capsule formulation under fasted and fed conditions will be assessed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Healthy male, age 18-50 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:
• 100 mg GLPG1205
A single dose of 100 mg GLPG1205 administered as two capsules of 50 mg

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 GLPG1205 in plasma	To characterize and compare the amount of GLPG1205 in plasma ( relative bioavailability) in male healthy subjects after a single administration of a capsule formulation in a fasted versus fed condition.	From predose up to 504 hours (Day 22) after study drug administration	No
Secondary	The number of subjects with adverse events	To evaluate the safety and tolerability of a single dose of GLPG1205 administered as capsules fasted versus fed in male healthy subjects in terms of adverse events (AEs)	From screening up to 28 (+/-2) days after last study drug administration	Yes
Secondary	The number of subjects with abnormal laboratory parameters	To evaluate the safety and tolerability of a single dose of GLPG1205 administered as capsules fasted versus fed in male healthy subjects in terms of abnormal laboratory parameters	From screening up to 28 (+/-2) days after last study drug administration	Yes
Secondary	The number of subjects with abnormal vital signs	To evaluate the safety and tolerability of a single dose of GLPG1205 administered as capsules fasted versus fed in male healthy subjects in terms of abnormal vital signs	From screening up to 28 (+/-2) days after last study drug administration	Yes
Secondary	The number of subjects with abnormal electrocardiogram (ECG)	To evaluate the safety and tolerability of a single dose of GLPG1205 administered as capsules fasted versus fed in male healthy subjects in terms of abnormal electrocardiogram (ECG)	From screening up to 28 (+/-2) days after last study drug administration	Yes
Secondary	The number of subjects with abnormal physical examination	To evaluate the safety and tolerability of a single dose of GLPG1205 administered as capsules fasted versus fed in male healthy subjects in terms of abnormal physical examination	From screening up to 28 (+/-2) days after last study drug administration	Yes