NCT06542536CompletedPhase 1
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
Investigation of Tolerability, Safety, and Pharmacokinetic Properties of a Single Oral Dose of Monlunabant in Male Japanese and Caucasian Participants With Normal Body Weight
Source: ClinicalTrials.gov · Last updated 18 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 73 (actual)
- First submitted
- 5 Aug 2024
- Start date
- 9 Aug 2024
- Primary completion date
- 25 Oct 2024
- Lead sponsor
- Novo Nordisk A/S
- Diseases
- Obesity
- NCT number
- NCT06542536
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 73
- From 9 Aug 2024 to the primary completion date, 25 Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous randomisation in this study.
- Previous rescreening for this study.
Other illness
- Known or suspected hypersensitivity to study intervention(s) or related products.
- 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.
Other
- A Patient Health Questionnaire 9 (PHQ-9) score greater than 9 as assessed at screening.
Who the study is looking for
- 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.
Age in the registry: 18 years to 55 years · Sex: Male · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Altasciences Clinical LA, Inc. Coordinator of this site? Confirm its status | Cypress | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.