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Completed

NCT Number: 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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Altasciences Clinical LA, Inc.

Cypress, California, 90630, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Monlunabant

Drug

Oral monlunabant

Placebo (monlunabant)

Drug

Oral placebo (monlunabant)

Primary outcomes

  1. Number of treatment emergent adverse events (TEAEs) after single dose of oral monlunabant

    Time frame: From dosing (day 1) to end of study visit (day 21)

    Number of events

Secondary outcomes

  1. AUC0-∞,monlunabant, SD; the area under the monlunabant plasma concentration-time curve from time 0 to infinity after single dose of oral monlunabant

    Time frame: From pre-dose (day 1) to end of study visit (day 21)

    h*nmol/L

  2. Cmax, monlunabant, SD; the maximum plasma concentration of monlunabant after single dose of oral monlunabant

    Time frame: From pre-dose (day 1) to end of study visit (day 21)

    nmol/L

  3. tmax,monlunabant, SD; the time of maximum observed plasma concentration of monlunabant single dose of oral monlunabant

    Time frame: From pre-dose (day 1) to end of study visit (day 21)

    h (hours)

  4. t½,monlunabant,SD; the terminal half-life of monlunabant after single dose of oral monlunabant

    Time frame: From pre-dose (day 1) to end of study visit (day 21)

    h (hours)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 7, 2024
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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