HealthyPhase 1NCT07214935
A TQT Study of Effect of M2951 on Cardiac Repolarization
A Phase 1 study testing Moxifloxacin, M2951 Low Dose and M2951 High Dose in people with Healthy, run by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany at 1 site in Germany.
Trial summary
The purpose of this study is to assess potential effects of M2951 on cardiac repolarization (i.e. prolongation of QT interval). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Moxifloxacin, M2951 Low Dose and M2951 High Dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteGermany
- Study dates
- 8 Nov 2022to 25 Aug 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants are overtly healthy as determined by medical evaluation, including no clinically significant abnormality identified on physical examination or laboratory evaluation and no active clinically significant disorder, condition, infection, or disease that would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion
- Participants have a body weight within 50.0 and 100.0 kilograms (kg) (inclusive) and body mass index (BMI) within the range 19.0 and 30.0 kilograms per square meter (kg/m^2) (inclusive)
- Participants are stable nonsmokers for at least 3 months preceding the first administration of study intervention
Who cannot join
- Participants with history or presence of clinically relevant respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, musculoskeletal, genitourinary, immunological, dermatological, connective tissue, psychiatric (due to rare risk of hallucinations, agitation, and activation of psychosis), and other diseases or disorders, and epilepsy, as determined by medical evaluation
- Participants with diagnosis of hemochromatosis, Wilson´s disease, alpha 1 antitrypsin deficiency, or any other chronic liver disease including Gilbert's disease will be excluded from the study. Prior history of cholecystectomy or splenectomy, and any clinically relevant surgery within 6 months prior to the first administration of study intervention
- Participants with history of any malignancy
- Participants with history of seizures
- Participants with history of pharmacologically treated psychiatric disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Dose, Randomized, Double-Blind, Placebo- and Positive-Controlled, 4-Way Crossover Study to Evaluate the Effect of Evobrutinib on the QTc (Corrected QT) Interval in Healthy Adult Participants
The purpose of this study is to assess potential effects of M2951 on cardiac repolarization (i.e. prolongation of QT interval).
- Conditions
- Healthy
- Being tested
- Placebo matched to M2951, Moxifloxacin, M2951 Low Dose, M2951 High Dose
- Keywords
- M2951, Bruton's Tyrosine Kinase, Cardiac Repolarization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo matched to M2951Drug
Participants will receive single oral dose of placebo matched to M2951 in either of study periods (period 1 or period 2 or period 3 or period 4) under fasted conditions.
MoxifloxacinDrug
Participants will receive single oral dose of moxifloxacin in either of study periods (period 1 or period 2 or period 3 or period 4) under fasted conditions.
M2951 Low DoseDrug
Also called Evobrutinib, MSC2364447C
Participants will receive single oral low dose of M2951 in either of study periods (period 1 or period 2 or period 3 or period 4) under fasted conditions.
M2951 High DoseDrug
Also called Evobrutinib, MSC2364447C
Participants will receive single oral high dose of M2951 in either of study periods (period 1 or period 2 or period 3 or period 4) under fasted conditions.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Sequence 1 | Experimental | Participants will receive one of the four interventions in a sequence decided at randomization. Receives: Drug: Placebo matched to M2951; Drug: Moxifloxacin; Drug: M2951 Low Dose; Drug: M2951 High Dose |
| Treatment Sequence 2 | Experimental | Participants will receive one of the four interventions in a sequence decided at randomization. Receives: Drug: Placebo matched to M2951; Drug: Moxifloxacin; Drug: M2951 Low Dose; Drug: M2951 High Dose |
| Treatment Sequence 3 | Experimental | Participants will receive one of the four interventions in a sequence decided at randomization. Receives: Drug: Placebo matched to M2951; Drug: Moxifloxacin; Drug: M2951 Low Dose; Drug: M2951 High Dose |
| Treatment Sequence 4 | Experimental | Participants will receive one of the four interventions in a sequence decided at randomization. Receives: Drug: Placebo matched to M2951; Drug: Moxifloxacin; Drug: M2951 Low Dose; Drug: M2951 High Dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Placebo-corrected Change From Baseline in Corrected QT Interval by Fridericia' Formula (QTcF) for Evobrutinib
A linear mixed-effects model was used to analyze the relationship between evobrutinib and MSC2729909A concentrations and ΔQTc. Based on this model, drug-induced ΔΔQTc and its two-sided 90% CI was predicted over the clinical concentration range and at concentrations corresponding to the observed geometric mean Cmax following administration of 45 mg and 225 mg evobrutinib. The higher geometric mean Cmax calculated based on the PK and ECG Analysis Sets was considered.
Measured: Baseline and from 1 hour before any administration until 24 hours post-administration at the following timepoints: -1-hour, 5 min, 10 min, 20 min, 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hours
Secondary outcomes (22)
Placebo-corrected Change From Baseline in Corrected QT Interval by Fridericia' Formula (QTcF) for Moxifloxacin
A linear mixed-effects model was used to analyze the relationship between moxifloxacin concentrations and ΔQTc. Based on this model, drug-induced ΔΔQTc and its two-sided 90% CI was predicted. The higher geometric mean Cmax calculated based on the PK and ECG Analysis Sets was considered.
Measured: From 1 hour before any administration until 24 hours post-administration at the following timepoints: -1-hour, 5 min, 10 min, 20 min, 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hours
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product, regardless of causal relationship with this treatment.Therefore, an AE can be any unfavorable and unintended sign (including an abnormallaboratory finding), symptom, or disease temporally associated with the use of amedicinal product, regardless if it is considered related to the medicinal product.Serious AE: AE that resulted in any of the following outcomes: death; life threatening;persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization;congenital anomaly/birth defect. TEAEs are defined as AEs that were reported orworsened on or after start of study drug dosing through the Safety Follow-up Visit.TEAEs included both serious TEAEs and non-serious TEAEs. Treatment related AEs:reasonably related to the study drug/study treatment.
Measured: Up to 3 months
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Based on Severity
Severity of adverse events (AE) were assessed by the investigator. The Investigator assessed the intensity of each AE and SAE reported during the study and assigned it to 1 of the following categories:
- Mild: A type of adverse event that is usually transient and may require only minimal treatment or therapeutic intervention. The event does not generally interfere with usual activities of daily living. 2. Moderate: A type of adverse event that is usually alleviated with additional specific therapeutic intervention. The event interferes with usual activities of daily living, causing discomfort but poses no significant or permanent risk of harm to the research participant. 3. Severe: A type of adverse event that interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Number of participants with severe adverse events were reported.
Measured: Up to 3 months
Number of Participants With Clinically Significant Abnormalities From Baseline in Safety Laboratory Tests
The laboratory measurements included hematology, blood chemistry and urinalysis. Number of participants with clinically significant abnormalities from baseline were reported. Clinically Significance was decided by investigator.
Measured: Up to Day 29
Number of Participants With Clinically Significant Abnormalities From Baseline in Vital Signs
Vital sign assessment included blood pressure, pulse rate, body temperature and respiration (frequency per minute). Number of participants with clinically significant abnormalities in vital signs were reported. Clinically significance was decided by investigator.
Measured: Up to Day 29
Number of Participants With Clinically Significant Changes From Baseline in Electroencephalogram (EEG) and Electrocardiogram (ECG) Findings
The 12-lead ECG recordings were obtained after 5 minutes of rest in a semi-supine position. ECG recordings included rhythm, ventricular rate, PR interval, QRS duration, QT and QTc intervals. Number of participants with clinically significant abnormalities were reported. Clinically significance was decided by investigator.
Measured: Up to Day 29
Area Under the Blood-Concentration Time Curve From Time Zero to 24 Hours Post-Dose (AUC 0-24) of Evobrutinib
AUC from time zero to 24 hours post dose, calculated using the mixed log linear trapezoidal rule (linear up, log down) using the nominal dosing interval.
Measured: Pre-dose up to 24 hours post-dose on Days 1, 8, 15, and 22
Area Under the Plasma-Concentration Time Curve From Time Zero Extrapolated to Infinity (AUC 0-inf) of Evobrutinib
The AUC from time zero (= dosing time) extrapolated to infinity, based on the predicted value for the concentration at t last, as estimated using the linear regression from lambda (λ)z determination.
Measured: Pre-dose up to 24 hours post-dose on Days 1, 8, 15, and 22
Maximum Observed Plasma Concentration (Cmax) of Evobrutinib
Cmax is the maximum observed plasma concentration. Cmax was obtained directly from the concentration versus time curve.
Measured: Pre-dose up to 24 hours post-dose on Days 1, 8, 15, and 22
Time to Reach Maximum Blood Concentration (Tmax) of Evobrutinib
Time to reach the maximum blood concentration (Tmax) was obtained directly from the concentration versus time curve.
Measured: Pre-dose up to 24 hours post-dose on Days 1, 8, 15, and 22
Apparent Terminal Half-life (t1/2) of Evobrutinib
Terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by lambda z.
Measured: Pre-dose up to 24 hours post-dose on Days 1, 8, 15, and 22
Area Under the Blood-Concentration Time Curve From Time Zero to 24 Hours Post-Dose (AUC 0-24) Of Moxifloxacin
AUC from time zero to 24 hours post dose, calculated using the mixed log linear trapezoidal rule (linear up, log down) using the nominal dosing interval.
Measured: Pre-dose up to 24 hours post-dose on Days 1, 8, 15, and 22
Maximum Observed Plasma Concentration (Cmax) of Moxifloxacin
Cmax is the maximum observed plasma concentration. Cmax was obtained directly from the concentration versus time curve.
Measured: Pre-dose up to 24 hours post-dose on Days 1, 8, 15, and 22
Area Under the Plasma-Concentration Time Curve From Time Zero Extrapolated to Infinity (AUC 0-inf) of Moxifloxacin
The AUC from time zero (= dosing time) extrapolated to infinity, based on the predicted value for the concentration at t last, as estimated using the linear regression from lambda (λ)z determination.
Measured: Pre-dose up to 24 hours post-dose on Days 1, 8, 15, and 22
Time to Reach Maximum Blood Concentration (Tmax) of Moxifloxacin
Time to reach the maximum blood concentration (Tmax) was obtained directly from the concentration versus time curve.
Measured: Pre-dose up to 24 hours post-dose on Days 1, 8, 15, and 22
Effect of Evobrutinib on ECG Parameters: ECG Mean Heart Rate
The effect of evobrutinib on baseline-corrected measurements of Heart rate was summarized by treatment and time points using descriptive statistics. Absolute change from baseline values was reported.
Measured: Baseline, and post-dose at 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, and 24 hours
Effect of Evobrutinib on ECG Parameters: RR Interval
The effect of evobrutinib on baseline-corrected measurements of RR interval was summarized by treatment and time points using descriptive statistics. Absolute change from baseline values was reported.
Measured: Baseline, and post-dose at 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, and 24 hours
Effect of Evobrutinib on ECG Parameters: QT Interval
The effect of evobrutinib on baseline-corrected measurements of QT interval was summarized by treatment and time points using descriptive statistics. Absolute change from baseline values was reported.
Measured: Baseline, and post-dose at 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, and 24 hours
Effect of Evobrutinib on ECG Parameters: QTcF Interval
The effect of evobrutinib on baseline-corrected measurements of QTcF was summarized by treatment and time points using descriptive statistics. Absolute change from baseline values was reported.
Measured: Baseline, and post-dose at 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, and 24 hours
Effect of Evobrutinib on ECG Parameters: QTcP Interval
The effect of evobrutinib on baseline-corrected measurements of QTcP was summarized by treatment and time points using descriptive statistics. Absolute change from baseline values was reported.
Measured: Baseline, and post-dose at 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, and 24 hours
Effect of Evobrutinib on ECG Parameters: PR Interval
The effect of evobrutinib on baseline-corrected measurements of PR interval was summarized by treatment and time points using descriptive statistics. Absolute change from baseline values was reported.
Measured: Baseline, and post-dose at 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, and 24 hours
Effect of Evobrutinib on ECG Parameters: QRS Duration
The effect of evobrutinib on baseline-corrected measurements of QRS duration was summarized by treatment and time points using descriptive statistics. Absolute change from baseline values was reported.
Measured: Baseline, and post-dose at 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, and 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start8 Nov 2022
- Primary completion25 Aug 2023
- Study completion25 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07214935
- Sponsor's protocol ID
- MS200527_0070
- Other IDs
- 2022-002664-78
- Status last verified
- Oct 2025
- First submitted
- 8 Oct 2025
- Last updated
- 13 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and the European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose, Randomized, Double-Blind, Placebo- and Positive-Controlled, 4-Way Crossover Study to Evaluate the Effect of Evobrutinib on the QTc (Corrected QT) Interval in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT07214935
- Acronym / sponsor ID
- MS200527_0070
- Conditions
- Healthy
- Keywords
- M2951, Bruton's Tyrosine Kinase, Cardiac Repolarization
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Study start
- 8 Nov 2022 (actual)
- Primary completion
- 25 Aug 2023 (actual)
- Study completion
- 25 Aug 2023 (actual)
- First posted
- 9 Oct 2025 (actual)
- Results
- Posted 13 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess potential effects of M2951 on cardiac repolarization (i.e. prolongation of QT interval).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment Sequence 1 | Experimental | Drug: Placebo matched to M2951, Drug: Moxifloxacin, Drug: M2951 Low Dose, Drug: M2951 High DoseParticipants will receive one of the four interventions in a sequence decided at randomization. |
| Treatment Sequence 2 | Experimental | Drug: Placebo matched to M2951, Drug: Moxifloxacin, Drug: M2951 Low Dose, Drug: M2951 High DoseParticipants will receive one of the four interventions in a sequence decided at randomization. |
| Treatment Sequence 3 | Experimental | Drug: Placebo matched to M2951, Drug: Moxifloxacin, Drug: M2951 Low Dose, Drug: M2951 High DoseParticipants will receive one of the four interventions in a sequence decided at randomization. |
| Treatment Sequence 4 | Experimental | Drug: Placebo matched to M2951, Drug: Moxifloxacin, Drug: M2951 Low Dose, Drug: M2951 High DoseParticipants will receive one of the four interventions in a sequence decided at randomization. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participants are overtly healthy as determined by medical evaluation, including no clinically significant abnormality identified on physical examination or laboratory evaluation and no active clinically significant disorder, condition, infection, or disease that would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion
- Participants have a body weight within 50.0 and 100.0 kilograms (kg) (inclusive) and body mass index (BMI) within the range 19.0 and 30.0 kilograms per square meter (kg/m^2) (inclusive)
- Participants are stable nonsmokers for at least 3 months preceding the first administration of study intervention
Key exclusion criteria (5 listed)
- Participants with history or presence of clinically relevant respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, musculoskeletal, genitourinary, immunological, dermatological, connective tissue, psychiatric (due to rare risk of hallucinations, agitation, and activation of psychosis), and other diseases or disorders, and epilepsy, as determined by medical evaluation
- Participants with diagnosis of hemochromatosis, Wilson´s disease, alpha 1 antitrypsin deficiency, or any other chronic liver disease including Gilbert's disease will be excluded from the study. Prior history of cholecystectomy or splenectomy, and any clinically relevant surgery within 6 months prior to the first administration of study intervention
- Participants with history of any malignancy
- Participants with history of seizures
- Participants with history of pharmacologically treated psychiatric disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo matched to M2951Participants will receive single oral dose of placebo matched to M2951 in either of study periods (period 1 or period 2 or period 3 or period 4) under fasted conditions. | Drug | Treatment Sequence 1, Treatment Sequence 2, Treatment Sequence 3, Treatment Sequence 4 |
| MoxifloxacinParticipants will receive single oral dose of moxifloxacin in either of study periods (period 1 or period 2 or period 3 or period 4) under fasted conditions. | Drug | Treatment Sequence 1, Treatment Sequence 2, Treatment Sequence 3, Treatment Sequence 4 |
| M2951 Low DoseAlso: Evobrutinib, MSC2364447CParticipants will receive single oral low dose of M2951 in either of study periods (period 1 or period 2 or period 3 or period 4) under fasted conditions. | Drug | Treatment Sequence 1, Treatment Sequence 2, Treatment Sequence 3, Treatment Sequence 4 |
| M2951 High DoseAlso: Evobrutinib, MSC2364447CParticipants will receive single oral high dose of M2951 in either of study periods (period 1 or period 2 or period 3 or period 4) under fasted conditions. | Drug | Treatment Sequence 1, Treatment Sequence 2, Treatment Sequence 3, Treatment Sequence 4 |
Primary outcome
Placebo-corrected Change From Baseline in Corrected QT Interval by Fridericia' Formula (QTcF) for Evobrutinib
Time frame: Baseline and from 1 hour before any administration until 24 hours post-administration at the following timepoints: -1-hour, 5 min, 10 min, 20 min, 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hours
A linear mixed-effects model was used to analyze the relationship between evobrutinib and MSC2729909A concentrations and ΔQTc. Based on this model, drug-induced ΔΔQTc and its two-sided 90% CI was predicted over the clinical concentration range and at concentrations corresponding to the observed geometric mean Cmax following administration of 45 mg and 225 mg evobrutinib. The higher geometric mean Cmax calculated based on the PK and ECG Analysis Sets was considered.
22 secondary outcomes
Placebo-corrected Change From Baseline in Corrected QT Interval by Fridericia' Formula (QTcF) for Moxifloxacin
Time frame: From 1 hour before any administration until 24 hours post-administration at the following timepoints: -1-hour, 5 min, 10 min, 20 min, 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hours
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to 3 months
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Based on Severity
Time frame: Up to 3 months
Number of Participants With Clinically Significant Abnormalities From Baseline in Safety Laboratory Tests
Time frame: Up to Day 29
Number of Participants With Clinically Significant Abnormalities From Baseline in Vital Signs
Time frame: Up to Day 29
Number of Participants With Clinically Significant Changes From Baseline in Electroencephalogram (EEG) and Electrocardiogram (ECG) Findings
Time frame: Up to Day 29
Area Under the Blood-Concentration Time Curve From Time Zero to 24 Hours Post-Dose (AUC 0-24) of Evobrutinib
Time frame: Pre-dose up to 24 hours post-dose on Days 1, 8, 15, and 22
Area Under the Plasma-Concentration Time Curve From Time Zero Extrapolated to Infinity (AUC 0-inf) of Evobrutinib
Time frame: Pre-dose up to 24 hours post-dose on Days 1, 8, 15, and 22
Maximum Observed Plasma Concentration (Cmax) of Evobrutinib
Time frame: Pre-dose up to 24 hours post-dose on Days 1, 8, 15, and 22
Time to Reach Maximum Blood Concentration (Tmax) of Evobrutinib
Time frame: Pre-dose up to 24 hours post-dose on Days 1, 8, 15, and 22
Apparent Terminal Half-life (t1/2) of Evobrutinib
Time frame: Pre-dose up to 24 hours post-dose on Days 1, 8, 15, and 22
Area Under the Blood-Concentration Time Curve From Time Zero to 24 Hours Post-Dose (AUC 0-24) Of Moxifloxacin
Time frame: Pre-dose up to 24 hours post-dose on Days 1, 8, 15, and 22
Maximum Observed Plasma Concentration (Cmax) of Moxifloxacin
Time frame: Pre-dose up to 24 hours post-dose on Days 1, 8, 15, and 22
Area Under the Plasma-Concentration Time Curve From Time Zero Extrapolated to Infinity (AUC 0-inf) of Moxifloxacin
Time frame: Pre-dose up to 24 hours post-dose on Days 1, 8, 15, and 22
Time to Reach Maximum Blood Concentration (Tmax) of Moxifloxacin
Time frame: Pre-dose up to 24 hours post-dose on Days 1, 8, 15, and 22
Effect of Evobrutinib on ECG Parameters: ECG Mean Heart Rate
Time frame: Baseline, and post-dose at 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, and 24 hours
Effect of Evobrutinib on ECG Parameters: RR Interval
Time frame: Baseline, and post-dose at 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, and 24 hours
Effect of Evobrutinib on ECG Parameters: QT Interval
Time frame: Baseline, and post-dose at 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, and 24 hours
Effect of Evobrutinib on ECG Parameters: QTcF Interval
Time frame: Baseline, and post-dose at 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, and 24 hours
Effect of Evobrutinib on ECG Parameters: QTcP Interval
Time frame: Baseline, and post-dose at 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, and 24 hours
Effect of Evobrutinib on ECG Parameters: PR Interval
Time frame: Baseline, and post-dose at 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, and 24 hours
Effect of Evobrutinib on ECG Parameters: QRS Duration
Time frame: Baseline, and post-dose at 15 minutes, 30 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, and 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Trial Awareness and Transparency websiteLink provided by the sponsor.
- Medical Information Location Map - Med Info ContactsLink provided by the sponsor.
- Individual participant dataSharing planned: No. We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and the European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Responsible study director
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Moxifloxacin, M2951 Low Dose and M2951 High Dose in people with Healthy, run by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of 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 5 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 13 Nov 2025. 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. 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?
Yes. Results are posted in the registry (first posted 13 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Placebo-corrected Change From Baseline in Corrected QT Interval by Fridericia' Formula (QTcF) for Evobrutinib (time frame: Baseline and from 1 hour before any administration until 24 hours post-administration at the following timepoints: -1-hour, 5 min, 10 min, 20 min, 0.5, 1, 1.5, 2, 3, 4, 8 and 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Nov 2025.