A Phase I, Open Interaction Study Between GLPG0634 and Midazolam in Healthy Subjects

Study Overview
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Brief Summary
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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.

Official Title
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A Phase I, Open Interaction Study Between Oral Doses of GLPG0634 (200 mg QD) and Single Oral Doses of Midazolam (2 mg) in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: GLPG0634
* Drug: Midazolam


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Midazolam and GLPG0634<br>Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions (Days 1 and 8) and multiple oral doses of GLPG0634 (200 mg daily for 7 days) from Days 2 to 8. | Drug: GLPG0634<br>* Each subject will receive multiple oral doses of GLPG0634 (200 mg daily for 7 days) from Days 2 to 8.<br>Drug: Midazolam<br>* Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions (Days 1 and 8)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The amount of (1'-OH) Midazolam in plasma over time before and after multiple oral doses of GLPG0634 | To characterize the amount of (1'-OH) Midazolam in plasma over time before and after multiple doses of GLPG0634 - pharmacokinetics (PK) - in healthy subjects | Between predose and up to 24h postdose on Day 1 and Day 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The amount of GLPG0634 and metabolite in plasma over time after multiple oral doses of GLPG0634 (and co-administration of Midazolam on Day 8) | 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 | Between predose (Day 2) and up to 96h after the last dose on Day 8 (on Day 12) | 
| Number of adverse events | 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 | Between screening and 7-10 days after the last dose of GLPG0634 (Day 15-18) | 
| Changes in vital signs as measured by pulse, supine blood pressure, oral temperature (and respiratory rate only 1 hour post Midazolam dosing) | 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 | Between screening and 7-10 days after the last dose of GLPG0634 (Day 15-18) | 
| Changes in 12-lead ECG measures | 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 | Between screening and 7-10 days after the last dose of GLPG0634 (Day 15-18) | 
| Changes in physical exam measures | 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 | Between screening and 7-10 days after the last dose of GLPG0634 (Day 15-18) | 
| Changes in blood safety lab parameters | 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 | Between screening and 7-10 days after the last dose of GLPG0634 (Day 15-18) | 
| Changes in urine safety lab parameters | 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 | Between screening and 7-10 days after the last dose of GLPG0634 (Day 15-18) |