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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-003668-13 | EudraCT Number |
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The study will investigate the effect of single dose and multiple doses of M2951 on midazolam Pharmacokinetics (PK) in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Midazolam and/or M2951 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midazolam | Drug | Participants will receive single oral dose of midazolam on Days 1, 3 and 13 under fed conditions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUC0-inf) of Midazolam | Pre-dose through 24 hours postdose on Days 1, 3 and 13 | |
| Maximum Observed Plasma Concentration (Cmax) of Midazolam | Pre-dose through 24 hours postdose on Days 1, 3 and 13 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment-Emergent Adverse Events (TEAEs) | Up to Day 14 | |
| Number of Participants with Treatment-Emergent Adverse Events (TEAEs) by Severity | Up to Day 14 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nuvisan GmbH | Neu-Ulm | 89231 | Germany |
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| Label | URL |
|---|---|
| Trial Awareness and Transparency website | View source |
| Medical Information Location Map - Med Info Contacts | View source |
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Per company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany, will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website https://www.merckgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html
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| ID | Term |
|---|---|
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| C000632111 | evobrutinib |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| M2951 | Drug | Participants will receive multiple oral doses (twice daily) of M2951 on Day 3 to Day 13 under fed conditions. |
|
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| Number of Participants with Clinically Significant Change From Baseline in Laboratory Parameters, Vital Signs and 12-Lead Electrocardiogram (ECG) Findings |
Number of participants with clinically significant change from baseline in laboratory parameters, vital signs and 12- lead ECG findings will be reported. |
| Up to Day 14 |
| Area Under the Plasma Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUC0-inf) of 1-hydroxymidazolam | Pre-dose through 24 hours postdose on Days 1, 3 and 13 |
| Maximum Observed Plasma Concentration (Cmax) of 1-hydroxymidazolam | Pre-dose through 24 hours postdose on Days 1, 3 and 13 |
| Time to Reach Maximum Plasma Concentration (tmax) of Midazolam and 1-hydroxymidazolam | Pre-dose through 24 hours postdose on Days 1, 3 and 13 |
| Apparent Terminal Half-life (t1/2) of Midazolam and 1-hydroxymidazolam | Pre-dose through 24 hours postdose on Days 1, 3 and 13 |
| Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC0-t) of Midazolam and 1-hydroxymidazolam | Pre-dose through 24 hours postdose on Days 1, 3 and 13 |
| Apparent Total Body Clearance (CL/F) of Midazolam | Pre-dose through 24 hours postdose on Days 1, 3 and 13 |
| Apparent Volume of Distribution (Vz/F) of Midazolam | Pre-dose through 24 hours postdose on Days 1, 3 and 13 |
| D006571 | Heterocyclic Compounds |