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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01820806
• Other study ID #: GLPG0634-CL-105
• Status: Completed
• Phase: Phase 1
• First received: March 26, 2013
• Last updated: May 5, 2013
• Start date: March 2013
• Est. completion date: April 2013

Study information

• Verified date: May 2013
• Source: Galapagos NV
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 65 Years

Eligibility

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

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• 100 mg dose of [14C] GLPG0634
Subjects will be dosed with a single oral 100 mg dose of [14C] GLPG0634 on one occasion

Locations

Country	Name	City	State
United Kingdom	Quotient Clinical	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Galapagos NV

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes