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

NCT01820806 | Completed Phase 1

• 1 other identifier: GLPG0634-CL-105
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• Number of adverse events

  Screening up to Day 10 post dosing

• Changes in vital signs as measured by heart rate, blood pressure and oral temperature

  Screening up to Day 10 post dosing

• Changes in 12-lead ECG measures

  Screening up to Day 10 post dosing

• Changes in physical exam measures

  Screening up to Day 10 post dosing

• Changes in blood safety lab parameters

  Screening up to Day 10 post dosing

Study Arms (1)

[14C] GLPG0634

EXPERIMENTAL

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

Drug: 100 mg dose of [14C] GLPG0634

Interventions

100 mg dose of [14C] GLPG0634 DRUG

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

[14C] GLPG0634

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Galapagos NV: lead

Study Sites (1)

Quotient Clinical

Nottingham, NG11 6JS, United Kingdom

Location

MeSH Terms

Interventions

GLPG0634

Study Officials

• Frédéric - Vanhoutte, MD

  Galapagos NV

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2013
• First Posted: March 29, 2013
• Study Start: March 1, 2013
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: May 7, 2013

Record last verified: 2013-05

Locations

GB (1)