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A TQT Study of Effect of M2951 on Cardiac Repolarization

NCT ID: NCT07214935

Last Updated: 2025-11-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-08

Study Completion Date

2023-08-25

Brief Summary

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

Detailed Description

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Conditions

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Healthy

Keywords

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M2951 Bruton's Tyrosine Kinase Cardiac Repolarization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment Sequence 1

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

Group Type EXPERIMENTAL

Placebo matched to M2951

Intervention Type 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.

Moxifloxacin

Intervention Type 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.

M2951 Low Dose

Intervention Type 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.

M2951 High Dose

Intervention Type 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.

Treatment Sequence 2

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

Group Type EXPERIMENTAL

Placebo matched to M2951

Intervention Type 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.

Moxifloxacin

Intervention Type 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.

M2951 Low Dose

Intervention Type 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.

M2951 High Dose

Intervention Type 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.

Treatment Sequence 3

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

Group Type EXPERIMENTAL

Placebo matched to M2951

Intervention Type 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.

Moxifloxacin

Intervention Type 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.

M2951 Low Dose

Intervention Type 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.

M2951 High Dose

Intervention Type 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.

Treatment Sequence 4

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

Group Type EXPERIMENTAL

Placebo matched to M2951

Intervention Type 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.

Moxifloxacin

Intervention Type 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.

M2951 Low Dose

Intervention Type 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.

M2951 High Dose

Intervention Type 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.

Interventions

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Placebo matched to M2951

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.

Intervention Type DRUG

Moxifloxacin

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.

Intervention Type DRUG

M2951 Low Dose

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.

Intervention Type DRUG

M2951 High Dose

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.

Intervention Type DRUG

Other Intervention Names

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Evobrutinib MSC2364447C Evobrutinib MSC2364447C

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Responsible

Role: STUDY_DIRECTOR

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

Locations

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Nuvisan GmbH

Neu-Ulm, , Germany

Site Status

Countries

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Germany

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://clinicaltrials.emdgroup.com/en/

Trial Awareness and Transparency website

https://www.merckgroup.com/en/company/contact-us/medinfo-contact-map.html

Medical Information Location Map - Med Info Contacts

Other Identifiers

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2022-002664-78

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MS200527_0070

Identifier Type: -

Identifier Source: org_study_id