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

December 2, 2019 updated by: Merck KGaA, Darmstadt, Germany

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
96

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Neu-Ulm, Germany, 89231
        • Nuvisan GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
PLACEBO_COMPARATOR: Part A: Placebo
Drug: Placebo
Participants will receive placebo matched to M5049.
EXPERIMENTAL: Part A: M5049
Drug: M5049
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.
EXPERIMENTAL: Part B: M5049
Drug: M5049
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_COMPARATOR: Part B: Placebo
Drug: Placebo
Participants will receive placebo matched to M5049.
EXPERIMENTAL: Part C: M5049
Drug: M5049
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Part A: Occurrence and Severity of Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs)
Time Frame: Day 1 up to Day 21
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
Time Frame: Day 1 up to Day 21
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
Time Frame: Day 1 up to Day 33
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
Time Frame: Day 1 up to Day 33
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
Time Frame: Pre-dose up to Day 6
Pre-dose up to Day 6
Part C: Time to Reach Maximum Plasma Concentration (tmax) of M5049
Time Frame: Pre-dose up to Day 6
Pre-dose up to Day 6
Part C: Elimination Rate Constant (λz) of M5049
Time Frame: Pre-dose up to Day 6
Pre-dose up to Day 6
Part C: Apparent Terminal Half-life (t1/2) of M5049
Time Frame: Pre-dose up to Day 6
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
Time Frame: Pre-dose up to Day 6
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)
Time Frame: Pre-dose up to Day 6
Pre-dose up to Day 6
Part C: Total Body Clearance (CL/f) of M5049
Time Frame: Pre-dose up to Day 6
Pre-dose up to Day 6
Part C: Apparent Volume of Distribution (Vz/f) of M5049
Time Frame: Pre-dose up to Day 6
Pre-dose up to Day 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Part A: Maximum Observed Blood Concentration (Cmax) of M5049
Time Frame: Pre-dose up to Day 6
Pre-dose up to Day 6
Part A: Time to Reach Maximum Plasma Concentration (tmax) of M5049
Time Frame: Pre-dose up to Day 6
Pre-dose up to Day 6
Part A: Elimination Rate Constant (λz) of M5049
Time Frame: Pre-dose up to Day 6
Pre-dose up to Day 6
Part A: Apparent Terminal Half-life (t1/2) of M5049
Time Frame: Pre-dose up to Day 6
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
Time Frame: Pre-dose up to Day 6
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)
Time Frame: Pre-dose up to Day 6
Pre-dose up to Day 6
Part A: Total Body Clearance (CL/f) of M5049
Time Frame: Pre-dose up to Day 6
Pre-dose up to Day 6
Part A: Apparent Volume of Distribution (Vz/f) of M5049
Time Frame: Pre-dose up to Day 6
Pre-dose up to Day 6
Part A: Dose Normalized Maximum Observed Plasma Concentration (Cmax/D) of M5049
Time Frame: Pre-dose up to Day 6
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
Time Frame: Pre-dose up to Day 6
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
Time Frame: Baseline, Day 2
Baseline, Day 2
Part A: Time Matched Plasma Concentration of M5049
Time Frame: Pre-dose up to Day 6
Pre-dose up to Day 6
Part B: Maximum Observed Blood Concentration (Cmax) of M5049
Time Frame: Pre-dose up to Day 19
Pre-dose up to Day 19
Part B: Time to Reach Maximum Plasma Concentration (tmax) of M5049
Time Frame: Pre-dose up to Day 19
Pre-dose up to Day 19
Part B: Elimination Rate Constant (λz) of M5049
Time Frame: Pre-dose up to Day 19
Pre-dose up to Day 19
Part B: Apparent Terminal Half-life (t1/2) of M5049
Time Frame: Pre-dose up to Day 19
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
Time Frame: Pre-dose up to Day 19
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)
Time Frame: Pre-dose up to Day 19
Pre-dose up to Day 19
Part B: Total Body Clearance (CL/f) of M5049
Time Frame: Pre-dose up to Day 19
Pre-dose up to Day 19
Part B: Apparent Volume of Distribution (Vz/f) of M5049
Time Frame: Pre-dose up to Day 19
Pre-dose up to Day 19
Part B: Area Under the Concentration-Time Curve Over the Dosing Interval (AUCtau)
Time Frame: Pre-dose up to Day 19
Pre-dose up to Day 19
Part B: Accumulation Ratio for Cmax (Racc Cmax) of M5049
Time Frame: Pre-dose up to Day 19
Pre-dose up to Day 19
Part B: Accumulation Ratio for AUCtau(Racc AUCtau) of M5049
Time Frame: Pre-dose up to Day 19
Pre-dose up to Day 19
Part B: Peak trough Ratio of M5049
Time Frame: Pre-dose up to Day 19
Pre-dose up to Day 19
Part B: Plasma Concentration Prior to the Next Dose (C trough) of M5049
Time Frame: Pre-dose up to Day 19
Pre-dose up to Day 19
Part B: Dose Normalized Maximum Observed Plasma Concentration at Steady State (Cmaxss/D) of M5049
Time Frame: Pre-dose up to Day 19
Pre-dose up to Day 19
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
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
Time Frame: Baseline, Day 2
Baseline, Day 2
Part B: Time Matched Plasma Concentration of M5049
Time Frame: Pre-dose up to Day 19
Pre-dose up to Day 19
Part C: Occurrence and Severity of Treatment-emergent Adverse Events (TEAEs) and Serious AEs (SAEs)
Time Frame: Day 1 up to Day 23
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
Time Frame: Day 1 up to Day 23
Number of participants with clinically significant changes will be reported.
Day 1 up to Day 23

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Merck KGaA, Darmstadt, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 20, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 26, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 26, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 17, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 18, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 3, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MS200569_0001
  • 2018-001256-35 (EUDRACT_NUMBER)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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