Healthy
Conditions
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.
Interventions
DRUG100 mg dose of [14C] GLPG0634
Subjects will be dosed with a single oral 100 mg dose of \[14C\] GLPG0634 on one occasion
Sponsors
Galapagos NV
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
United Kingdom
Outcome results
None listed