Investigation of the Pharmacokinetics and Metabolism of GLPG0634 in Healthy Male Subjects

Investigation of the Pharmacokinetics and Metabolism of GLPG0634 in Healthy Male Subjects Following a Single Oral Administration of [14C] GLPG0634

This will be a study in 6 healthy male subjects, each receiving a single oral dose of 100 mg [14C]-radiolabeled GLPG0634.

The study aims to establish the elimination pathways of GLPG0634 and their relative significance and to assess the metabolite profile of GLPG0634 in plasma and in excreta.

Furthermore, the pharmacokinetics (PK) of the main metabolites in plasma relative to GLPG0634 will be evaluated.

This study will also provide safety and tolerability information for GLPG0634.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: 100 mg dose of [14C] GLPG0634

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham, United Kingdom, NG11 6JS
    • Quotient Clinical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• male, between 40 and 65 years of age, inclusive
• within BMI range 18 to 30 kg/m2, inclusive

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [14C] GLPG0634; Subjects will be dosed with a single oral 100 mg dose of [14C] GLPG0634 on one occasion	Drug: 100 mg dose of [14C] GLPG0634; Subjects will be dosed with a single oral 100 mg dose of [14C] GLPG0634 on one occasion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The amount of total radioactivity in urine and faeces over time after a single dose of radiolabeled GLPG0634	To evaluate the mass balance recovery of total radioactivity in urine, faeces, and urine and faeces combined to determine the elimination pathways and their relative significance after a single dose of radiolabeled GLPG0634	Day -1 (pre-dosing) up to Day 10 post dosing
The amount of GLPG0634 and its main metabolites in urine and faeces over time after a single dose of radiolabeled GLPG0634	To evaluate the recovery of GLPG0634 and its main metabolites in urine and faeces after a single dose of radiolabeled GLPG0634 to determine the elimination pathways and their relative significance (excretion and renal clearance)	Day -1 (pre-dosing) up to Day 10 post dosing
Identification of metabolites over time in plasma, urine and faeces after a single dose of radiolabeled GLPG0634	Metabolite profiling and identification in plasma, urine and faeces over time after a single dose of radiolabeled GLPG0634	Day -1 (pre-dosing) up to Day 10 post dosing
The amount of radioactivity, GLPG0634 and its main metabolites in blood and plasma over time after a single dose of radiolabeled GLPG0634	To characterize the amount of radioactivity, GLPG0634 and its main metabolites in blood and plasma over time after a single dose of radiolabeled GLPG0634	Day 1 (pre-dosing) up to Day 8 post dosing

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of adverse events	To evaluate the safety and tolerability of GLPG0634 after a single dose of radiolabeled GLPG0634 in terms of the number of adverse events reported	Screening up to Day 10 post dosing
Changes in vital signs as measured by heart rate, blood pressure and oral temperature	To evaluate the safety and tolerability of GLPG0634 after a single dose of radiolabeled GLPG0634 in terms of changes in vital signs as measured by heart rate, blood pressure and oral temperature reported	Screening up to Day 10 post dosing
Changes in 12-lead ECG measures	To evaluate the safety and tolerability of GLPG0634 after a single dose of radiolabeled GLPG0634 in terms of changes in 12-ECG measures reported	Screening up to Day 10 post dosing
Changes in physical exam measures	To evaluate the safety and tolerability of GLPG0634 after a single dose of radiolabeled GLPG0634 in terms of changes in physical exam measures reported	Screening up to Day 10 post dosing
Changes in blood safety lab parameters	To evaluate the safety and tolerability of GLPG0634 after a single dose of radiolabeled GLPG0634 in terms of changes in blood safety lab parameters reported	Screening up to Day 10 post dosing
Changes in urine safety lab parameters	To evaluate the safety and tolerability of GLPG0634 after a single dose of radiolabeled GLPG0634 in terms of changes in urine safety lab parameters reported	Screening up to Day 10 post dosing

Collaborators and Investigators

• Sponsor: Galapagos NV
• Investigators: Study Director: Frédéric - Vanhoutte, MD, Galapagos NV

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: March 26, 2013
• First Submitted That Met QC Criteria: March 26, 2013
• First Posted (Estimate): March 29, 2013

Study Record Updates

• Last Update Posted (Estimate): May 7, 2013
• Last Update Submitted That Met QC Criteria: May 5, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: GLPG0634-CL-105