Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2019-004738-40 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study will evaluate the relative bioavailability (rBA) of the intended commercial tablet formulation (Test Treatment, TF2) of Evobrutinib compared to the clinical tablet formulation (Reference Treatment, TF1) of Evobrutinib and to assess the effect of food on the bioavailability of the intended commercial tablet formulation of Evobrutinib.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Evobrutinib: Treatment Sequence 1: A-B-C | Experimental | Participants will receive single oral dose of TF1 (Treatment A) evobrutinib on Day 1 under fasted condition in period 1, followed by single oral dose of TF2 (Treatment B) on Day 3 under fasted condition in period 2, followed by TF2 (Treatment C) on Day 5 under fed condition in period 3. There will be 48 hours washout period between each treatment period. |
|
| Evobrutinib: Treatment Sequence 2: A-C-B | Experimental | Participants will receive single oral dose of TF1 (Treatment A) evobrutinib on Day 1 under fasted condition in period 1, followed by TF2 (Treatment C) on Day 3 under fed condition in period 2, followed by single oral dose of TF2 (Treatment B) on Day 5 under fasted condition in period 3. There will be 48 hours washout period between each treatment period. |
|
| Evobrutinib: Treatment Sequence 3: B-A-C | Experimental | Participants will receive single oral dose of TF2 (Treatment B) on Day 1 under fasted condition in period 1, followed by single oral dose of TF1 (Treatment A) evobrutinib on Day 3 under fasted condition in period 2, followed by TF2 (Treatment C) on Day 5 under fed condition in period 3. There will be 48 hours washout period between each treatment period. |
|
| Evobrutinib: Treatment Sequence 4: B-C-A | Experimental | Participants will receive single oral dose of TF2 (Treatment B) on Day 1 under fasted condition in period 1, followed by TF2 (Treatment C) on Day 3 under fed condition in period 2, followed by single oral dose of TF1 (Treatment A) evobrutinib on Day 5 under fasted condition in period 3. There will be 48 hours washout period between each treatment period. |
| 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 and Treatment B), or under fed conditions that is within 30 minutes after start of high-fat meal (Treatment C) in period 1, 2 and 3. |
| 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 Under Fasted Conditions | Pre-dose up to 24 hours post-dose on Day 6 | |
| Area Under the Plasma Concentration-Time Curve from Time Zero to Infinity (AUC0-inf) of Evobrutinib Under Fasted Conditions | Pre-dose up to 24 hours post-dose on Day 6 | |
| Maximum Observed Plasma Concentration (Cmax) of Evobrutinib Under Fasted Conditions | Pre-dose up to 24 hours post-dose on Day 6 | |
| Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-t) of Evobrutinib Under Fed Conditions | Pre-dose up to 24 hours post-dose on Day 6 | |
| Area Under the Plasma Concentration-Time Curve from Time Zero to Infinity (AUC0-inf) of Evobrutinib Under Fed Conditions | Pre-dose up to 24 hours post-dose on Day 6 | |
| Maximum Observed Plasma Concentration (Cmax) of Evobrutinib Under Fed Conditions | Pre-dose up to 24 hours post-dose on Day 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment -Emergent Adverse Events (TEAEs) Based on Severity Under Fasted Conditions | Day 1 up to Day 6 | |
| Number of Participants With Clinically Significant Change From Baseline in Vital Signs, Laboratory Parameters and Electrocardiogram Findings Under Fasted Conditions |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 | Germany |
Not provided
| Label | URL |
|---|---|
| Trial Awareness and Transparency website | View source |
| Medical Information Location Map - Med Info Contacts | View source |
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Evobrutinib: Treatment Sequence 5: C-A-B | Experimental | Participants will receive single oral dose of TF2 (Treatment C) on Day 1 under fed condition in period 1, followed by single oral dose of TF1 (Treatment A) evobrutinib on Day 3 under fasted condition in period 2, followed by single oral dose of TF2 (Treatment B) on Day 5 under fasted condition in period 3. There will be 48 hours washout period between each treatment period. |
|
| Evobrutinib: Treatment Sequence 6: C-B-A | Experimental | Participants will receive single oral dose of TF2 (Treatment C) on Day 1 under fed condition in period 1, followed by single oral dose of TF2 (Treatment B) on Day 3 under fasted condition in period 2, followed by single oral dose of TF1 (Treatment A) evobrutinib on Day 5 under fasted condition in period 3. There will be 48 hours washout period between each treatment period. |
|
|
Number of participants with clinically significant change from baseline in vital signs, laboratory parameters and electrocardiogram findings will be reported
| Day 1 up to Day 6 |
| Area Under the Plasma Concentration-Time Curve From Time Zero to Time 24 Hours After Evobrutinib Administration (AUC0-24) | Pre-dose up to 24 hours post-dose on Day 6 |
| Area Under The Plasma Concentration-Time Curve From Time Zero to Time 12 Hours After Evobrutinib Administration (AUC0-12) | Pre-dose up to 12 hours post-dose on Day 6 |
| Time to Reach Maximum Plasma Concentration (Tmax) of Evobrutinib | Pre-dose up to 24 hours post-dose on Day 6 |
| Time Prior to the First Measurable (non-zero) Concentration (t lag) of Evobrutinib | Pre-dose up to 24 hours post-dose on Day 6 |
| Terminal First Order (elimination) Rate Constant (λz) of Evobrutinib | Pre-dose up to 24 hours post-dose on Day 6 |
| Apparent Elimination Half Life (t1/2) of Evobrutinib | Pre-dose up to 24 hours post-dose on Day 6 |
| Apparent Total Body Clearance (CL/f) of Evobrutinib | Pre-dose up to 24 hours post-dose on Day 6 |
| Apparent Volume of Distribution During Terminal Phase (VZ/f) of Evobrutinib | Pre-dose up to 24 hours post-dose on Day 6 |
| Relative Bioavailability of Test Treatment in Relation to Reference Treatment (Frel) | Pre-dose up to 24 hours post-dose on Day 6 |
| ID | Term |
|---|---|
| C000632111 | evobrutinib |
Not provided
Not provided
Not provided