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Completed

NCT Number: NCT03676322

Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study of M5049 in Healthy Participants

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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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Nuvisan GmbH

Neu-Ulm, 89231, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Placebo

Drug

Participants will receive placebo matched to M5049.

Primary outcomes

  1. Part A: Occurrence and Severity of Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs)

    Time frame: Day 1 up to Day 21

  2. Part A: Number of Participants With Clinically Significant Changes in Vital Signs, Laboratory Parameters and 12-lead Electrocardiogram (ECG) Findings

    Time frame: Day 1 up to Day 21

    Number of participants with clinically significant changes will be reported.

  3. Part B: Occurrence and Severity of TEAEs and SAEs

    Time frame: Day 1 up to Day 33

  4. Part B: Number of Participants With Clinically Significant Changes in Vital Signs, Laboratory Parameters and 12-lead Electrocardiogram (ECG) Findings

    Time frame: Day 1 up to Day 33

    Number of participants with clinically significant changes will be reported.

  5. Part C: Maximum Observed Plasma Concentration (Cmax) of M5049

    Time frame: Pre-dose up to Day 6

  6. Part C: Time to Reach Maximum Plasma Concentration (tmax) of M5049

    Time frame: Pre-dose up to Day 6

  7. Part C: Elimination Rate Constant (λz) of M5049

    Time frame: Pre-dose up to Day 6

  8. Part C: Apparent Terminal Half-life (t1/2) of M5049

    Time frame: Pre-dose up to Day 6

  9. Part C: Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC 0-t) of M5049

    Time frame: Pre-dose up to Day 6

  10. Part C: Area Under the Concentration-Time Curve Over Entire Dosing Time Period From Time Zero Extrapolated to Infinity (AUC0-inf)

    Time frame: Pre-dose up to Day 6

  11. Part C: Total Body Clearance (CL/f) of M5049

    Time frame: Pre-dose up to Day 6

  12. Part C: Apparent Volume of Distribution (Vz/f) of M5049

    Time frame: Pre-dose up to Day 6

Secondary outcomes

  1. Part A: Maximum Observed Blood Concentration (Cmax) of M5049

    Time frame: Pre-dose up to Day 6

  2. Part A: Time to Reach Maximum Plasma Concentration (tmax) of M5049

    Time frame: Pre-dose up to Day 6

  3. Part A: Elimination Rate Constant (λz) of M5049

    Time frame: Pre-dose up to Day 6

  4. Part A: Apparent Terminal Half-life (t1/2) of M5049

    Time frame: Pre-dose up to Day 6

  5. Part A: Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC 0-t) of M5049

    Time frame: Pre-dose up to Day 6

  6. Part A: Area Under the Concentration-Time Curve Over Entire Dosing Time Period From Time Zero Extrapolated to Infinity (AUC0-inf)

    Time frame: Pre-dose up to Day 6

  7. Part A: Total Body Clearance (CL/f) of M5049

    Time frame: Pre-dose up to Day 6

  8. Part A: Apparent Volume of Distribution (Vz/f) of M5049

    Time frame: Pre-dose up to Day 6

  9. Part A: Dose Normalized Maximum Observed Plasma Concentration (Cmax/D) of M5049

    Time frame: Pre-dose up to Day 6

  10. Part A: Dose Normalized Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC0-t/D) of M5049

    Time frame: Pre-dose up to Day 6

  11. Part A: Change From Baseline in QT Interval Corrected Using Fridericia's Formula (QTcF) on Digital Holter Electrocardiograms (ECG) at Day 2

    Time frame: Baseline, Day 2

  12. Part A: Time Matched Plasma Concentration of M5049

    Time frame: Pre-dose up to Day 6

  13. Part B: Maximum Observed Blood Concentration (Cmax) of M5049

    Time frame: Pre-dose up to Day 19

  14. Part B: Time to Reach Maximum Plasma Concentration (tmax) of M5049

    Time frame: Pre-dose up to Day 19

  15. Part B: Elimination Rate Constant (λz) of M5049

    Time frame: Pre-dose up to Day 19

  16. Part B: Apparent Terminal Half-life (t1/2) of M5049

    Time frame: Pre-dose up to Day 19

  17. Part B: Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC 0-t) of M5049

    Time frame: Pre-dose up to Day 19

  18. Part B: Area Under the Concentration-Time Curve Over Entire Dosing Time Period From Time Zero Extrapolated to Infinity (AUC0-inf)

    Time frame: Pre-dose up to Day 19

  19. Part B: Total Body Clearance (CL/f) of M5049

    Time frame: Pre-dose up to Day 19

  20. Part B: Apparent Volume of Distribution (Vz/f) of M5049

    Time frame: Pre-dose up to Day 19

  21. Part B: Area Under the Concentration-Time Curve Over the Dosing Interval (AUCtau)

    Time frame: Pre-dose up to Day 19

  22. Part B: Accumulation Ratio for Cmax (Racc Cmax) of M5049

    Time frame: Pre-dose up to Day 19

  23. Part B: Accumulation Ratio for AUCtau(Racc AUCtau) of M5049

    Time frame: Pre-dose up to Day 19

  24. Part B: Peak trough Ratio of M5049

    Time frame: Pre-dose up to Day 19

  25. Part B: Plasma Concentration Prior to the Next Dose (C trough) of M5049

    Time frame: Pre-dose up to Day 19

  26. Part B: Dose Normalized Maximum Observed Plasma Concentration at Steady State (Cmaxss/D) of M5049

    Time frame: Pre-dose up to Day 19

  27. Part B: Dose Normalized Area Under the Concentration-Time Curve Over the Dosing Interval (AUCtau/D) of M5049

    Time frame: Pre-dose up to Day 19

  28. Part B: Change From Baseline in QT Interval Corrected Using Fridericia's Formula (QTcF) on Digital Holter Electrocardiograms (ECG) at Day 2

    Time frame: Baseline, Day 2

  29. Part B: Time Matched Plasma Concentration of M5049

    Time frame: Pre-dose up to Day 19

  30. Part C: Occurrence and Severity of Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs)

    Time frame: Day 1 up to Day 23

  31. Part C: Number of Participants With Clinically Significant Changes in Vital Signs, Laboratory Parameters and 12-lead Electrocardiogram (ECG) Findings

    Time frame: Day 1 up to Day 23

    Number of participants with clinically significant changes will be reported.

Sponsors and collaborators

Lead sponsor

Merck KGaA, Darmstadt, Germany

Industry

Registry information

Official study title

A Phase I, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses and Multiple Ascending Doses of M5049 Administered Orally in Healthy Participants

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 18, 2018
Registry last updated
Dec 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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