Status:
COMPLETED
A TQT Study of Effect of M2951 on Cardiac Repolarization
Lead Sponsor:
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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
- 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
- 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
Key Trial Info
Start Date :
November 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 25 2023
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT07214935
Start Date
November 8 2022
End Date
August 25 2023
Last Update
November 13 2025
Active Locations (1)
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1
Nuvisan GmbH
Neu-Ulm, Germany