A TQT Study of Effect of M2951 on Cardiac Repolarization

NCT07214935 | Completed Phase 1 Results

• 2 other identifiers: MS200527_00702022-002664-78
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess potential effects of M2951 on cardiac repolarization (i.e. prolongation of QT interval).

Conditions

Healthy

Keywords

M2951; Bruton's Tyrosine Kinase; Cardiac Repolarization

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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)

  Up to 3 months

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Based on Severity

  Up to 3 months

• Number of Participants With Clinically Significant Abnormalities From Baseline in Safety Laboratory Tests

  Up to Day 29

• Number of Participants With Clinically Significant Abnormalities From Baseline in Vital Signs

  Up to Day 29

Study Arms (4)

Treatment Sequence 1

EXPERIMENTAL

Participants will receive one of the four interventions in a sequence decided at randomization.

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.

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.

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.

Drug: Placebo matched to M2951; Drug: Moxifloxacin; Drug: M2951 Low Dose; Drug: M2951 High Dose

Interventions

Placebo matched to M2951 DRUG

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.

Treatment Sequence 1; Treatment Sequence 2; Treatment Sequence 3; Treatment Sequence 4

Moxifloxacin DRUG

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.

Treatment Sequence 1; Treatment Sequence 2; Treatment Sequence 3; Treatment Sequence 4

M2951 Low Dose DRUG

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.

Also known as: Evobrutinib, MSC2364447C

Treatment Sequence 1; Treatment Sequence 2; Treatment Sequence 3; Treatment Sequence 4

M2951 High Dose DRUG

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.

Also known as: Evobrutinib, MSC2364447C

Treatment Sequence 1; Treatment Sequence 2; Treatment Sequence 3; Treatment Sequence 4

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany: lead

Study Sites (1)

Nuvisan GmbH

Neu-Ulm, Germany

Location

Related Links

• Trial Awareness and Transparency website
• Medical Information Location Map - Med Info Contacts

MeSH Terms

Interventions

Moxifloxacin; evobrutinib

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Communication Center
• Organization: Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, Germany

service@emdgroup.com

+49-6151-72-5200

Study Officials

• Medical Responsible

  Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2025
• First Posted: October 9, 2025
• Study Start: November 8, 2022
• Primary Completion: August 25, 2023
• Study Completion: August 25, 2023
• Last Updated: November 13, 2025
• Results First Posted: November 13, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)