Clinical trial NCT06542536: 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
Official title: Investigation of Tolerability, Safety, and Pharmacokinetic Properties of a Single Oral Dose of Monlunabant in Male Japanese and Caucasian Participants With Normal Body Weight
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2024-08-07
Enrollment: 73
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 18.5-24.9 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.

Primary outcomes:
measure: Number of treatment emergent adverse events (TEAEs) after single dose of oral monlunabant
timeFrame: From dosing (day 1) to end of study visit (day 21)
Secondary outcomes:
measure: AUC0-∞,monlunabant, SD; the area under the monlunabant plasma concentration-time curve from time 0 to infinity after single dose of oral monlunabant
timeFrame: From pre-dose (day 1) to end of study visit (day 21)
measure: Cmax, monlunabant, SD; the maximum plasma concentration of monlunabant after single dose of oral monlunabant
timeFrame: From pre-dose (day 1) to end of study visit (day 21)
measure: tmax,monlunabant, SD; the time of maximum observed plasma concentration of monlunabant single dose of oral monlunabant
timeFrame: From pre-dose (day 1) to end of study visit (day 21)
measure: t½,monlunabant,SD; the terminal half-life of monlunabant after single dose of oral monlunabant
timeFrame: From pre-dose (day 1) to end of study visit (day 21)
Other outcomes:
Locations:
city: Cypress
country: United States
facility: Altasciences Clinical LA, Inc.
state: California
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: