A TQT Study of Effect of M2951 on Cardiac Repolarization

Merck KGaA (EMD Serono)

Status and phase: Completed; Phase 1

Conditions: Healthy

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT07214935

MS200527_0070

2022-002664-78 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 36 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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36 participants in 4 patient groups

Treatment Sequence 1

Experimental group

Description:

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

Treatment:

Drug: Moxifloxacin

Drug: Placebo matched to M2951

Drug: M2951 Low Dose

Drug: M2951 High Dose

Treatment Sequence 2

Experimental group

Description:

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

Treatment:

Drug: Moxifloxacin

Drug: Placebo matched to M2951

Drug: M2951 Low Dose

Drug: M2951 High Dose

Treatment Sequence 3

Experimental group

Description:

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

Treatment:

Drug: Moxifloxacin

Drug: Placebo matched to M2951

Drug: M2951 Low Dose

Drug: M2951 High Dose

Treatment Sequence 4

Experimental group

Description:

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

Treatment:

Drug: Moxifloxacin

Drug: Placebo matched to M2951

Drug: M2951 Low Dose

Drug: M2951 High Dose