Phase 1
N=36
A TQT Study of Effect of M2951 on Cardiac Repolarization
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT07214935 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcome: Primary: Placebo-corrected Change From Baseline in Corrected QT Interval by Fridericia' Formula (QTcF) for Evobrutinib — -1.62; -2.28 milliseconds
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Placebo matched to M2951 (Drug); Moxifloxacin (Drug); M2951 Low Dose (Drug); M2951 High Dose (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
- Primary completion
- Aug 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Placebo-corrected Change From Baseline in Corrected QT Interval by Fridericia' Formula (QTcF) for Evobrutinib |
-1.62; -2.28 | — |
| SECONDARY Placebo-corrected Change From Baseline in Corrected QT Interval by Fridericia' Formula (QTcF) for Moxifloxacin |
12.2 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
8; 5; 5; 8 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Based on Severity |
0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormalities From Baseline in Safety Laboratory Tests |
0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Abnormalities From Baseline in Vital Signs |
0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Clinically Significant Changes From Baseline in Electroencephalogram (EEG) and Electrocardiogram (ECG) Findings |
0; 0; 0; 0 | — |
| SECONDARY Area Under the Blood-Concentration Time Curve From Time Zero to 24 Hours Post-Dose (AUC 0-24) of Evobrutinib |
249; 1420 | — |
| SECONDARY Area Under the Plasma-Concentration Time Curve From Time Zero Extrapolated to Infinity (AUC 0-inf) of Evobrutinib |
248; 1420 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of Evobrutinib |
123; 670 | — |
| SECONDARY Time to Reach Maximum Blood Concentration (Tmax) of Evobrutinib |
0.500; 0.500 | — |
| SECONDARY Apparent Terminal Half-life (t1/2) of Evobrutinib |
1.32; 2.09 | — |
| SECONDARY Area Under the Blood-Concentration Time Curve From Time Zero to 24 Hours Post-Dose (AUC 0-24) Of Moxifloxacin |
19600 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of Moxifloxacin |
2000 | — |
| SECONDARY Area Under the Plasma-Concentration Time Curve From Time Zero Extrapolated to Infinity (AUC 0-inf) of Moxifloxacin |
24900 | — |
| SECONDARY Time to Reach Maximum Blood Concentration (Tmax) of Moxifloxacin |
1.50 | — |
| SECONDARY Effect of Evobrutinib on ECG Parameters: ECG Mean Heart Rate |
58.1; 58.6; 58.7; 57.9; 0.6; 1.3 | — |
| SECONDARY Effect of Evobrutinib on ECG Parameters: RR Interval |
1057.4; 1044.0; 1043.4; 1056.1; -14.8; -24.4 | — |
| SECONDARY Effect of Evobrutinib on ECG Parameters: QT Interval |
395.8; 393.2; 394.5; 396.4; -0.1; -1.5 | — |
| SECONDARY Effect of Evobrutinib on ECG Parameters: QTcF Interval |
389.4; 388.4; 389.8; 390.0; 1.6; 1.6 | — |
| SECONDARY Effect of Evobrutinib on ECG Parameters: QTcP Interval |
388.2; 387.5; 389.1; 388.9; 1.9; 2.1 | — |
| SECONDARY Effect of Evobrutinib on ECG Parameters: PR Interval |
166.7; 170.4; 167.7; 167.1; -0.2; -1.2 | — |
| SECONDARY Effect of Evobrutinib on ECG Parameters: QRS Duration |
91.7; 91.8; 91.7; 91.0; 0.1; 0.3 | — |
Summary
The purpose of this study is to assess potential effects of M2951 on cardiac repolarization (i.e. prolongation of QT interval).
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT07214935). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.