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HealthyPhase 1NCT03676322

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

A Phase 1 study testing M5049 in people with Healthy, run by Merck KGaA, Darmstadt, Germany at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
M5049
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
96 participants
Where
1 siteGermany
Study dates
20 Sep 2018to 26 Jul 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Nuvisan GmbH

    Neu-Ulm, 89231

Other trials in Germany

About this study

Official 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

The study will evaluate the safety, tolerability, Pharmacokinetic (PK), Pharmacodynamics (PD), and explore the food effect of M5049 in healthy male and female participants.

Conditions
Healthy
Being tested
M5049, Placebo
Keywords
Pharmacokinetics, M5049

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • M5049Drug

    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.

  • PlaceboDrug

    Participants will receive placebo matched to M5049.

Study groups in NCT03676322
Study groupRoleWhat they receive
Part A: M5049ExperimentalNot described
Receives: Drug: M5049
Part A: PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo
Part B: M5049ExperimentalNot described
Receives: Drug: M5049
Part B: PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo
Part C: M5049ExperimentalNot described
Receives: Drug: M5049

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 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

    Number of participants with clinically significant changes will be reported.

    Measured: Day 1 up to Day 21

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

    Measured: 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

    Number of participants with clinically significant changes will be reported.

    Measured: Day 1 up to Day 33

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

    Measured: Pre-dose up to Day 6

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

    Measured: Pre-dose up to Day 6

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

    Measured: Pre-dose up to Day 6

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

    Measured: 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

    Measured: 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)

    Measured: Pre-dose up to Day 6

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

    Measured: Pre-dose up to Day 6

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

    Measured: Pre-dose up to Day 6

Secondary outcomes (31)

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

    Measured: Pre-dose up to Day 6

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

    Measured: Pre-dose up to Day 6

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

    Measured: Pre-dose up to Day 6

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

    Measured: 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

    Measured: 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)

    Measured: Pre-dose up to Day 6

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

    Measured: Pre-dose up to Day 6

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

    Measured: Pre-dose up to Day 6

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

    Measured: 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

    Measured: 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

    Measured: Baseline, Day 2

  12. Part A: Time Matched Plasma Concentration of M5049

    Measured: Pre-dose up to Day 6

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

    Measured: Pre-dose up to Day 19

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

    Measured: Pre-dose up to Day 19

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

    Measured: Pre-dose up to Day 19

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

    Measured: 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

    Measured: 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)

    Measured: Pre-dose up to Day 19

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

    Measured: Pre-dose up to Day 19

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

    Measured: Pre-dose up to Day 19

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

    Measured: Pre-dose up to Day 19

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

    Measured: Pre-dose up to Day 19

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

    Measured: Pre-dose up to Day 19

  24. Part B: Peak trough Ratio of M5049

    Measured: Pre-dose up to Day 19

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

    Measured: Pre-dose up to Day 19

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

    Measured: 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

    Measured: 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

    Measured: Baseline, Day 2

  29. Part B: Time Matched Plasma Concentration of M5049

    Measured: Pre-dose up to Day 19

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

    Measured: 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

    Number of participants with clinically significant changes will be reported.

    Measured: Day 1 up to Day 23

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2018
  2. Study start20 Sep 2018
  3. Primary completion26 Jul 2019
  4. Study completion26 Jul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03676322
Sponsor's protocol ID
MS200569_0001
Other IDs
2018-001256-35, 2018
Status last verified
Nov 2019
First submitted
17 Sep 2018
Last updated
3 Dec 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing M5049 in people with Healthy, run by Merck KGaA, Darmstadt, Germany at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A: Occurrence and Severity of Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs) (time frame: Day 1 up to Day 21). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03676322.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2019.

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Clinical Trial NCT03676322 | AzTrials