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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: 100 mg dose of [14C] GLPG0634

• Registration Number: NCT01820806
• Lead Sponsor: Galapagos NV

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-26
• Study First Submitted QC: 2013-03-26
• Study First Posted: 2013-03-29
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-05
• Last Update Posted: 2013-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[14C] GLPG0634	100 mg dose of [14C] GLPG0634	Subjects will be dosed with a single oral 100 mg dose of \[14C\] GLPG0634 on one occasion

Primary Outcome Measures

Name	Time	Method
The amount of total radioactivity in urine and faeces over time after a single dose of radiolabeled GLPG0634	Day -1 (pre-dosing) up to Day 10 post dosing	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
The amount of GLPG0634 and its main metabolites in urine and faeces over time after a single dose of radiolabeled GLPG0634	Day -1 (pre-dosing) up to Day 10 post dosing	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)
Identification of metabolites over time in plasma, urine and faeces after a single dose of radiolabeled GLPG0634	Day -1 (pre-dosing) up to Day 10 post dosing	Metabolite profiling and identification in plasma, urine and faeces over time after a single dose of radiolabeled GLPG0634
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	To characterize the amount of radioactivity, GLPG0634 and its main metabolites in blood and plasma over time after a single dose of radiolabeled GLPG0634

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Quotient Clinical; 🇬🇧 Nottingham, United Kingdom