Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study of M5049 in Healthy Participants
- Registration Number
- NCT03676322
- Lead Sponsor
- Merck KGaA, Darmstadt, Germany
- Brief Summary
The study will evaluate the safety, tolerability, Pharmacokinetic (PK), Pharmacodynamics (PD), and explore the food effect of M5049 in healthy male and female participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 96
Inclusion Criteria
- Body weight between 50 to 100 kilogram (kg)
- Body mass index (BMI) between 18.5 and 29.9 kilogram per meter square (kg/m^2)
- Other protocol defined inclusion criteria could apply
Exclusion Criteria
- History of clinically relevant disease of any organ system that may interfere with the objectives of the study or provide a risk to the health of the participant
- History of splenectomy
- History of epilepsy, other neurological disorders, or neuropsychiatric conditions
- Other protocol defined exclusion criteria could apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part B: M5049 M5049 - Part A: Placebo Placebo - Part C: M5049 M5049 - Part B: Placebo Placebo - Part A: M5049 M5049 -
- Primary Outcome Measures
Name Time Method 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 Day 1 up to Day 21 Number of participants with clinically significant changes will be reported.
Part C: Apparent Terminal Half-life (t1/2) 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 C: Maximum Observed Plasma Concentration (Cmax) of M5049 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: 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 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 Day 1 up to Day 33 Number of participants with clinically significant changes will be reported.
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: Total Body Clearance (CL/f) of M5049 Pre-dose up to Day 6
- Secondary Outcome Measures
Name Time Method 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 C: Occurrence and Severity of Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs) Day 1 up to Day 23 Part A: Time to Reach Maximum Plasma Concentration (tmax) 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: 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 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 A: Elimination Rate Constant (λz) of M5049 Pre-dose up to Day 6 Part A: Total Body Clearance (CL/f) of M5049 Pre-dose up to Day 6 Part B: Apparent Terminal Half-life (t1/2) 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: Accumulation Ratio for AUCtau(Racc AUCtau) 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 A: Apparent Terminal Half-life (t1/2) of M5049 Pre-dose up to Day 6 Part C: Number of Participants With Clinically Significant Changes in Vital Signs, Laboratory Parameters and 12-lead Electrocardiogram (ECG) Findings Day 1 up to Day 23 Number of participants with clinically significant changes will be reported.
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: 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: 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 A: Maximum Observed Blood Concentration (Cmax) of M5049 Pre-dose up to Day 6 Part A: Time Matched Plasma Concentration of M5049 Pre-dose up to Day 6 Part B: Elimination Rate Constant (λz) of M5049 Pre-dose up to Day 19 Part B: Peak trough Ratio 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 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 B: Total Body Clearance (CL/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: Dose Normalized Maximum Observed Plasma Concentration at Steady State (Cmaxss/D) of M5049 Pre-dose up to Day 19 Part B: Time Matched Plasma Concentration of M5049 Pre-dose up to Day 19
Trial Locations
- Locations (1)
Nuvisan GmbH
🇩🇪Neu-Ulm, Germany