Healthy
Conditions
Brief summary
This will be a drug-drug interaction study to evaluate the effect of multiple oral doses of GLPG0634 on the single dose pharmacokinetic profile of midazolam administered in fasted normal healthy males. Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions: on Day 1, before dosing with GLPG0634 and on Day 8, after multiple oral doses of GLPG0634 (daily for 7 days). Also, the safety and tolerability of multiple oral doses of GLPG0634 co-administered with midazolam in healthy male subjects will be evaluated.
Interventions
DRUGGLPG0634
Each subject will receive multiple oral doses of GLPG0634 (200 mg daily for 7 days) from Days 2 to 8.
DRUGMidazolam
Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions (Days 1 and 8)
Sponsors
Galapagos NV
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* male, between 40 and 60 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 (1'-OH) Midazolam in plasma over time before and after multiple oral doses of GLPG0634 | Between predose and up to 24h postdose on Day 1 and Day 8 | To characterize the amount of (1'-OH) Midazolam in plasma over time before and after multiple doses of GLPG0634 - pharmacokinetics (PK) - in healthy subjects |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of adverse events | Between screening and 7-10 days after the last dose of GLPG0634 (Day 15-18) | To evaluate the safety and tolerability of GLPG0634 after multiple oral doses in healthy subjects with or without coadministration of Midazolam in terms of the number of adverse events reported |
| Changes in vital signs as measured by pulse, supine blood pressure, oral temperature (and respiratory rate only 1 hour post Midazolam dosing) | Between screening and 7-10 days after the last dose of GLPG0634 (Day 15-18) | To evaluate the safety and tolerability of GLPG0634 after multiple oral doses in healthy subjects with or without coadministration of Midazolam in terms of changes in vital signs as measured by pulse, supine blood pressure, oral temperature (and respiratory rate) reported |
| Changes in 12-lead ECG measures | Between screening and 7-10 days after the last dose of GLPG0634 (Day 15-18) | To evaluate the safety and tolerability of GLPG0634 after multiple oral doses in healthy subjects with or without coadministration of Midazolam in terms of changes in 12-ECG measures reported |
| The amount of GLPG0634 and metabolite in plasma over time after multiple oral doses of GLPG0634 (and co-administration of Midazolam on Day 8) | Between predose (Day 2) and up to 96h after the last dose on Day 8 (on Day 12) | To characterize the amount of GLPG0634 and metabolite in plasma over time after multiple doses of GLPG0634 (and co-administration of Midazolam on Day 8) - pharmacokinetics (PK) - in healthy subjects |
| Changes in blood safety lab parameters | Between screening and 7-10 days after the last dose of GLPG0634 (Day 15-18) | To evaluate the safety and tolerability of GLPG0634 after multiple oral doses in healthy subjects with or without coadministration of Midazolam in terms of changes in blood safety lab parameters reported |
| Changes in urine safety lab parameters | Between screening and 7-10 days after the last dose of GLPG0634 (Day 15-18) | To evaluate the safety and tolerability of GLPG0634 after multiple oral doses in healthy subjects with or without coadministration of Midazolam in terms of changes in urine safety lab parameters reported |
| Changes in physical exam measures | Between screening and 7-10 days after the last dose of GLPG0634 (Day 15-18) | To evaluate the safety and tolerability of GLPG0634 after multiple oral doses in healthy subjects with or without coadministration of Midazolam in terms of changes in physical examination reported |
Countries
United States
Outcome results
None listed