Investigation of Tolerability, Safety, and Pharmacokinetic Properties of a Single Oral Dose of Monlunabant in Male Japanese and Caucasian Participants With Normal Body Weight
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 73
- Locations
- 1
- Primary Endpoint
- Number of treatment emergent adverse events (TEAEs) after single dose of oral monlunabant
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Sponsor staff involved in the clinical trial is masked according to company standard procedures
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Arms & Interventions
Monlunabant dose 1
Dose 1 of monlunabant treatment
Intervention: Monlunabant (Drug)
Monlunabant dose 2
Dose 2 of monlunabant treatment
Intervention: Monlunabant (Drug)
Monlunabant dose 3
Dose 3 of the monlunabant treatment
Intervention: Monlunabant (Drug)
Placebo (monlunabant)
Placebo treatment
Intervention: Placebo (monlunabant) (Drug)
Outcomes
Primary Outcomes
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
- 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))
- 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))
- 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))
- 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))