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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-005408-20 | EudraCT Number |
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The purpose of this study is to evaluate and determine the safety, tolerability and pharmacokinetics of single-doses of M5049 up to 3 dose levels administered as film-coated tablet under fasted conditions in healthy Japanese and Caucasian participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Japanese: M5049 Dose A (low dose) | Experimental |
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| Japanese: M5049 Dose B (medium dose) | Experimental |
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| Japanese: M5049 Dose C (high dose) | Experimental |
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| Caucasian: M5049 Dose A (low dose) | Experimental |
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| Caucasian: M5049 Dose B (medium dose) | Experimental |
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| Caucasian: M5049 Dose C (high dose) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| M5049 | Drug | Participants will receive single oral dose of film-coated tablet M5049 at low dose on Day 1 under fasted condition. |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Sampling Time (tlast) (AUC0-tlast) of M5049 | Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose | |
| Area Under Plasma Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUC0-inf) of M5049 | Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose | |
| Maximum Observed Plasma Concentration (Cmax) of M5049 | Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose | |
| Number of Participants with Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Death | Baseline up to Day 8 | |
| Number of Participants with Clinically Significant Changes from Baseline in Laboratory Parameters | Baseline up to Day 3 | |
| Number of Participants with Clinically Significant Changes from Baseline in Vital Signs | Baseline up to Day 3 | |
| Number of Participants with Clinically Significant Changes from Baseline in 12-lead Electrocardiogram (ECGs) Findings | Baseline up to Day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-Time Curve From Time Zero to 48 Hours Post-dose (AUC0-48) of M5049 | Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose | |
| Time to Reach Maximum Plasma Concentration (tmax) of M5049 |
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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 |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit Ltd. | Leeds | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38415785 | Derived | Klopp-Schulze L, Gopalakrishnan S, Yalkinoglu O, Kuroki Y, Lu H, Goteti K, Krebs-Brown A, Nogueira Filho M, Gradhand U, Fluck M, Shaw J, Dong J, Venkatakrishnan K. Asia-Inclusive Global Development of Enpatoran: Results of an Ethno-Bridging Study, Intrinsic/Extrinsic Factor Assessments and Disease Trajectory Modeling to Inform Design of a Phase II Multiregional Clinical Trial. Clin Pharmacol Ther. 2024 Jun;115(6):1346-1357. doi: 10.1002/cpt.3216. Epub 2024 Feb 28. |
| Label | URL |
|---|---|
| Trial Awareness and Transparency website | 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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| M5049 | Drug | Participants will receive single oral dose of film-coated tablet M5049 at medium dose on Day 1 under fasted condition. |
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| M5049 | Drug | Participants will receive single oral dose of film-coated tablet M5049 at high dose on Day 1 under fasted condition. |
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| Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose |
| Terminal Half-life (t1/2) of M5049 | Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose |
| Apparent Total Body Clearance (CL/f) of M5049 | Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose |
| Apparent Volume of Distribution (Vz/f) During Terminal Phase of M5049 | Pre-dose, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 24, 36 and 48 hours post-dose |
| Medical Information Location Map - Med Info Contacts | View source |