Status:
COMPLETED
A Research Study Investigating Safety and Concentration in the Blood After One Dose Tablet of the New Medicine Monlunabant in Healthy Weight Japanese and Caucasian Men
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Obesity
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
The study is testing a new study drug in healthy normal weight Japanese and Caucasian participants after a single dose. The aim of this study is to see if the new medicine is safe and how it works in ...
Eligibility Criteria
Inclusion
- Male.
- Age 18-55 years (both inclusive) at the time of signing the informed consent.
- Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
- For Japanese participants, both parents of Japanese descent and both paternal and maternal grandparents of Japanese descent.
- For Caucasian participants, self-reported European descent or white Latin-American descent.
- BMI 18.5-24.9 kg/m\^2 (both inclusive) at screening.
Exclusion
- Known or suspected hypersensitivity to study intervention(s) or related products.
- Previous randomisation in this study.
- Previous rescreening for this study.
- History of Major Depressive Disorder within the last 2 years from screening.
- Presence or history of any psychiatric disorders (e.g., schizophrenia, bipolar disorder, eating disorders, depression, and anxiety) as judged by the investigator.
- Suicidal ideation corresponding to type 4 or 5 or suicidal behaviour on the Columbia-Suicide Severity Rating Scale (C-SSRS) as assessed at screening or any history of suicidal attempts.
- A Patient Health Questionnaire 9 (PHQ-9) score greater than 9 as assessed at screening.
Key Trial Info
Start Date :
August 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 25 2024
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT06542536
Start Date
August 9 2024
End Date
October 25 2024
Last Update
November 18 2025
Active Locations (1)
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1
Altasciences Clinical LA, Inc.
Cypress, California, United States, 90630