A TQT Study of Effect of M2951 on Cardiac Repolarization

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo matched to M2951; Drug: Moxifloxacin; Drug: M2951 Low Dose; Drug: M2951 High Dose

• Registration Number: NCT07214935
• Lead Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-08
• Primary Completion: 2023-08-25
• Study Completion: 2023-08-25
• Status Verified: 2025-08
• Study First Submitted: 2025-10-08
• Study First Submitted QC: 2025-10-08
• Last Update Submitted: 2025-10-08
• Study First Posted: 2025-10-09
• Last Update Posted: 2025-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment Sequence 1	Placebo matched to M2951	Participants will receive one of the four interventions in a sequence decided at randomization.
Treatment Sequence 2	M2951 High Dose	Participants will receive one of the four interventions in a sequence decided at randomization.
Treatment Sequence 3	Placebo matched to M2951	Participants will receive one of the four interventions in a sequence decided at randomization.
Treatment Sequence 3	Moxifloxacin	Participants will receive one of the four interventions in a sequence decided at randomization.
Treatment Sequence 1	Moxifloxacin	Participants will receive one of the four interventions in a sequence decided at randomization.
Treatment Sequence 2	Moxifloxacin	Participants will receive one of the four interventions in a sequence decided at randomization.
Treatment Sequence 1	M2951 Low Dose	Participants will receive one of the four interventions in a sequence decided at randomization.
Treatment Sequence 1	M2951 High Dose	Participants will receive one of the four interventions in a sequence decided at randomization.
Treatment Sequence 2	Placebo matched to M2951	Participants will receive one of the four interventions in a sequence decided at randomization.
Treatment Sequence 2	M2951 Low Dose	Participants will receive one of the four interventions in a sequence decided at randomization.
Treatment Sequence 3	M2951 Low Dose	Participants will receive one of the four interventions in a sequence decided at randomization.
Treatment Sequence 3	M2951 High Dose	Participants will receive one of the four interventions in a sequence decided at randomization.
Treatment Sequence 4	Placebo matched to M2951	Participants will receive one of the four interventions in a sequence decided at randomization.
Treatment Sequence 4	Moxifloxacin	Participants will receive one of the four interventions in a sequence decided at randomization.
Treatment Sequence 4	M2951 Low Dose	Participants will receive one of the four interventions in a sequence decided at randomization.
Treatment Sequence 4	M2951 High Dose	Participants will receive one of the four interventions in a sequence decided at randomization.

Primary Outcome Measures

Name	Time	Method
Placebo-corrected Change from Baseline Corrected QT interval by Fridericia' formula (QTcF) for M2951	Baseline, Day 29

Secondary Outcome Measures

Name	Time	Method
Placebo-corrected Change from Baseline Corrected QT interval by Fridericia' formula (QTcF) for Moxifloxacin	Baseline, Day 29
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and TEAEs by Severity	up to Day 29
Number of Participants with Abnormal Changes from Baseline in Safety Laboratory Tests, Vital Signs and 12-Lead Electrocardiogram (ECG)	up to Day 29
Pharmacokinetic (PK) Plasma Concentrations of M2951	Pre-dose up to 24 hours post-dose on Days 1, 8, 15, and 22
Pharmacokinetic (PK) Plasma Concentrations of Moxifloxacin	Pre-dose up to 24 hours post-dose on Days 1, 8, 15, and 22

Trial Locations

Locations (1)

Nuvisan GmbH; 🇩🇪 Neu-Ulm, Germany