| ID | Type | Description | Link |
|---|---|---|---|
| 2019-000877-21 | EudraCT Number |
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This study will evaluate the Pharmacokinetics (PK) of the Phase II tablet formulation of Evobrutinib under fasted conditions, within 30 minutes after start of a light meal, one hour prior to start of a low-fat meal, and 2 hours after start of a low-fat meal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Evobrutinib: Treatment Sequence A, B, C, D | Experimental | Participant will receive single oral dose of evobrutinib after an overnight fast of at least 10 hours (Treatment A) for 3 days, followed by within 30 minutes after start of a light meal (Treatment B) for 2 days, followed by 1 hour prior to a low-fat meal (Treatment C) for 2 days, followed by 2 hours after start of low-fat meal (Treatment D) for 2 days. There will be 48 hours washout period between each treatment period. |
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| Evobrutinib: Treatment Sequence B, D, A, C | Experimental | Participant will receive single oral dose of evobrutinib within 30 minutes after start of a light meal (Treatment B) for 3 days, followed by 2 hours after start of a low-fat meal (Treatment D) for 2 days, followed by after an oversight fast of at least 10 hours (Treatment A) for 2 days, followed by 1 hour prior to a low-fat meal (Treatment C) for 2 days. There will be 48 hours washout period between each treatment period. |
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| Evobrutinib: Treatment Sequence C, A, D, B | Experimental | Participant will receive single oral dose of evobrutinib 1 hour prior to a low-fat meal (Treatment C) for 3 days, followed by after an oversight fast of at least 10 hours (Treatment A) for 2 days, followed by 2 hours after start of a low-fat meal (Treatment D) for 2 days followed by within 30 minutes after start of a light meal (Treatment B) for 2 days. There will be 48 hours washout period between each treatment period. |
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| Evobrutinib: Treatment Sequence D, C, B, A | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evobrutinib | Drug | Participants will receive single oral dose of evobrutinib either after an overnight fast of at least 10 hours (Treatment A), within 30 minutes after start of a light meal (Treatment B), 1 hour prior to a low-fat meal (Treatment C), or 2 hours after start of a low-fat meal (Treatment D). |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-t) of Evobrutinib | Pre-dose up to 24 hours post-dose | |
| Area Under the Plasma Concentration-Time Curve from Time Zero to Infinity (AUC0-inf) of Evobrutinib | Pre-dose up to 24 hours post-dose | |
| Maximum Plasma Concentration Observed (Cmax) of Evobrutinib | Pre-dose up to 24 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment -Emergent Adverse Events (TEAEs) | Day 1 up to Day 9 | |
| Number of Participants With Clinically Significant Change From Baseline in Vital Signs, Laboratory Parameters and Electrocardiogram Findings | Number of participants with clinically significant change from baseline in vital signs, laboratory parameters and electrocardiogram findings will be reported |
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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 |
|---|---|
| C000632111 | evobrutinib |
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Participant will receive single oral dose of evobrutinib 2 hours after start of a low-fat meal (Treatment D) for 3 days, followed by 1 hour prior to a low-fat meal (Treatment C) for 2 days, followed by within 30 minutes after start of a light meal (Treatment B) for 2 days, followed by after an overnight fast of at least 10 hours (Treatment A) for 2 days. There will be 48 hours washout period between each treatment period. |
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| Day 1 up to Day 9 |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Time 24 Hours After Drug Administration (AUC0-24) of Evobrutinib | Pre-dose up to 24 hours post-dose |
| Area Under The Concentration-Time Curve from Time Zero to Time 12 Hours (AUC0-12) of Evobrutinib | Pre-dose up to 12 Hours post-dose |
| Time to Reach Maximum Concentration (Tmax) of Evobrutinib in Plasma | Pre-dose up to 24 hours post-dose |
| Time Prior to the First Measurable (non-zero) Concentration of Evobrutinib | Pre-dose up to 24 hours post-dose |
| Apparent Elimination Half Life (t1/2) of Evobrutinib | Pre-dose up to 24 hours post-dose |
| Apparent Clearance (CL/f) of Evobrutinib | Pre-dose up to 24 hours post-dose |
| Apparent Volume of Distribution During Terminal Phase (VZ/f) of Evobrutinib | Pre-dose up to 24 hours post-dose |