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
- Registration Number
- NCT06542536
- Lead Sponsor
- Novo Nordisk A/S
- 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 the participants body. Oral monlunabant is a new medicine which cannot be prescribed by doctors but has previously been tested in humans. The participant will either get monlunabant or placebo or a combination of both. Which treatment the participant get is decided by chance. The study will last for about 49 days in total.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 73
Inclusion Criteria
- 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 18.5-22.9 kg/m^2 (both inclusive) at screening.
Exclusion Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Monlunabant dose 1 Monlunabant Dose 1 of monlunabant treatment Monlunabant dose 2 Monlunabant Dose 2 of monlunabant treatment Monlunabant dose 3 Monlunabant Dose 3 of the monlunabant treatment Placebo (monlunabant) Placebo (monlunabant) Placebo treatment
- Primary Outcome Measures
Name Time Method Number of treatment emergent adverse events (TEAEs) after single dose of oral monlunabant From dosing (day 1) to end of study visit (day 21) Number of events
- Secondary Outcome Measures
Name Time Method tmax,monlunabant, SD; the time of maximum observed plasma concentration of monlunabant single dose of oral monlunabant From pre-dose (day 1) to end of study visit (day 21) h (hours)
Cmax, monlunabant, SD; the maximum plasma concentration of monlunabant after single dose of oral monlunabant From pre-dose (day 1) to end of study visit (day 21) nmol/L
AUC0-∞,monlunabant, SD; the area under the monlunabant plasma concentration-time curve from time 0 to infinity after single dose of oral monlunabant From pre-dose (day 1) to end of study visit (day 21) h\*nmol/L
t½,monlunabant,SD; the terminal half-life of monlunabant after single dose of oral monlunabant From pre-dose (day 1) to end of study visit (day 21) h (hours)
Trial Locations
- Locations (1)
Altasciences Clinical LA, Inc.
🇺🇸Cypress, California, United States