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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-001256-35 | EudraCT Number |
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The study will evaluate the safety, tolerability, Pharmacokinetic (PK), Pharmacodynamics (PD), and explore the food effect of M5049 in healthy male and female participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: M5049 | Experimental |
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| Part A: Placebo | Placebo Comparator |
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| Part B: M5049 | Experimental |
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| Part B: Placebo | Placebo Comparator |
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| Part C: M5049 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| M5049 | Drug | Participants will receive single ascending oral dose of M5049 in Part A. Participants will receive multiple ascending oral dose of M5049 once daily for 14 days or twice daily for 13 days followed by a single dose on Day 14 in the morning in Part B. Participants will receive a single oral dose of M5049 under fed conditions in Part C. |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Occurrence and Severity of Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs) | Day 1 up to Day 21 | |
| Part A: Number of Participants With Clinically Significant Changes in Vital Signs, Laboratory Parameters and 12-lead Electrocardiogram (ECG) Findings | Number of participants with clinically significant changes will be reported. | Day 1 up to Day 21 |
| Part B: Occurrence and Severity of TEAEs and SAEs | Day 1 up to Day 33 | |
| Part B: Number of Participants With Clinically Significant Changes in Vital Signs, Laboratory Parameters and 12-lead Electrocardiogram (ECG) Findings | Number of participants with clinically significant changes will be reported. | Day 1 up to Day 33 |
| Part C: Maximum Observed Plasma Concentration (Cmax) of M5049 | Pre-dose up to Day 6 | |
| Part C: Time to Reach Maximum Plasma Concentration (tmax) of M5049 | Pre-dose up to Day 6 | |
| Part C: Elimination Rate Constant (λz) of M5049 | Pre-dose up to Day 6 | |
| Part C: Apparent Terminal Half-life (t1/2) of M5049 | Pre-dose up to Day 6 | |
| Part C: Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC 0-t) of M5049 |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Maximum Observed Blood Concentration (Cmax) of M5049 | Pre-dose up to Day 6 | |
| Part A: Time to Reach Maximum Plasma Concentration (tmax) of M5049 | Pre-dose up to Day 6 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nuvisan GmbH | Neu-Ulm | 89231 | Germany |
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| Placebo | Drug | Participants will receive placebo matched to M5049. |
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| Pre-dose up to Day 6 |
| Part C: Area Under the Concentration-Time Curve Over Entire Dosing Time Period From Time Zero Extrapolated to Infinity (AUC0-inf) | Pre-dose up to Day 6 |
| Part C: Total Body Clearance (CL/f) of M5049 | Pre-dose up to Day 6 |
| Part C: Apparent Volume of Distribution (Vz/f) of M5049 | Pre-dose up to Day 6 |
| Part A: Elimination Rate Constant (λz) of M5049 |
| Pre-dose up to Day 6 |
| Part A: Apparent Terminal Half-life (t1/2) of M5049 | Pre-dose up to Day 6 |
| Part A: Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC 0-t) of M5049 | Pre-dose up to Day 6 |
| Part A: Area Under the Concentration-Time Curve Over Entire Dosing Time Period From Time Zero Extrapolated to Infinity (AUC0-inf) | Pre-dose up to Day 6 |
| Part A: Total Body Clearance (CL/f) of M5049 | Pre-dose up to Day 6 |
| Part A: Apparent Volume of Distribution (Vz/f) of M5049 | Pre-dose up to Day 6 |
| Part A: Dose Normalized Maximum Observed Plasma Concentration (Cmax/D) of M5049 | Pre-dose up to Day 6 |
| Part A: Dose Normalized Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC0-t/D) of M5049 | Pre-dose up to Day 6 |
| Part A: Change From Baseline in QT Interval Corrected Using Fridericia's Formula (QTcF) on Digital Holter Electrocardiograms (ECG) at Day 2 | Baseline, Day 2 |
| Part A: Time Matched Plasma Concentration of M5049 | Pre-dose up to Day 6 |
| Part B: Maximum Observed Blood Concentration (Cmax) of M5049 | Pre-dose up to Day 19 |
| Part B: Time to Reach Maximum Plasma Concentration (tmax) of M5049 | Pre-dose up to Day 19 |
| Part B: Elimination Rate Constant (λz) of M5049 | Pre-dose up to Day 19 |
| Part B: Apparent Terminal Half-life (t1/2) of M5049 | Pre-dose up to Day 19 |
| Part B: Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC 0-t) of M5049 | Pre-dose up to Day 19 |
| Part B: Area Under the Concentration-Time Curve Over Entire Dosing Time Period From Time Zero Extrapolated to Infinity (AUC0-inf) | Pre-dose up to Day 19 |
| Part B: Total Body Clearance (CL/f) of M5049 | Pre-dose up to Day 19 |
| Part B: Apparent Volume of Distribution (Vz/f) of M5049 | Pre-dose up to Day 19 |
| Part B: Area Under the Concentration-Time Curve Over the Dosing Interval (AUCtau) | Pre-dose up to Day 19 |
| Part B: Accumulation Ratio for Cmax (Racc Cmax) of M5049 | Pre-dose up to Day 19 |
| Part B: Accumulation Ratio for AUCtau(Racc AUCtau) of M5049 | Pre-dose up to Day 19 |
| Part B: Peak trough Ratio of M5049 | Pre-dose up to Day 19 |
| Part B: Plasma Concentration Prior to the Next Dose (C trough) of M5049 | Pre-dose up to Day 19 |
| Part B: Dose Normalized Maximum Observed Plasma Concentration at Steady State (Cmaxss/D) of M5049 | Pre-dose up to Day 19 |
| Part B: Dose Normalized Area Under the Concentration-Time Curve Over the Dosing Interval (AUCtau/D) of M5049 | Pre-dose up to Day 19 |
| Part B: Change From Baseline in QT Interval Corrected Using Fridericia's Formula (QTcF) on Digital Holter Electrocardiograms (ECG) at Day 2 | Baseline, Day 2 |
| Part B: Time Matched Plasma Concentration of M5049 | Pre-dose up to Day 19 |
| Part C: Occurrence and Severity of Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs) | Day 1 up to Day 23 |
| Part C: Number of Participants With Clinically Significant Changes in Vital Signs, Laboratory Parameters and 12-lead Electrocardiogram (ECG) Findings | Number of participants with clinically significant changes will be reported. | Day 1 up to Day 23 |