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Monlunabant Safety Study in Healthy Individuals

Phase 1
Recruiting
Research Sponsored by Novo Nordisk A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male
Age 18-55 years at the time of signing the informed consent
Must not have
History of Major Depressive Disorder within the last 2 years from screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from dosing (day 1) to end of study visit (day 21)
Awards & highlights

Summary

This trial is testing a new experimental drug called monlunabant in healthy Japanese and Caucasian individuals of normal weight. The goal is to determine the safety and effectiveness of the drug after a single dose.

Who is the study for?
This trial is for healthy, normal-weight Japanese and Caucasian men who are interested in testing a new medication called Monlunabant. Participants will be randomly assigned to receive either the study drug or a placebo.
What is being tested?
The trial is examining the safety of Monlunabant and how it's processed in the body after one dose. It compares effects between those taking the actual drug and those receiving an inactive pill (placebo) over approximately 49 days.
What are the potential side effects?
Since this summary doesn't provide specific side effects, we can say: Potential side effects are not detailed here but generally could include reactions at the site of administration, general discomfort, or other symptoms as observed during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am male.
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I am between 18 and 55 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with Major Depressive Disorder in the last 2 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from dosing (day 1) to end of study visit (day 21)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from dosing (day 1) to end of study visit (day 21) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of treatment emergent adverse events (TEAEs) after single dose of oral monlunabant
Secondary study objectives
AUC0-∞,monlunabant, SD; the area under the monlunabant plasma concentration-time curve from time 0 to infinity after single dose of oral monlunabant
Cmax, monlunabant, SD; the maximum plasma concentration of monlunabant after single dose of oral monlunabant
tmax,monlunabant, SD; the time of maximum observed plasma concentration of monlunabant single dose of oral monlunabant
+1 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Monlunabant dose 3Experimental Treatment1 Intervention
Dose 3 of the monlunabant treatment
Group II: Monlunabant dose 2Experimental Treatment1 Intervention
Dose 2 of monlunabant treatment
Group III: Monlunabant dose 1Experimental Treatment1 Intervention
Dose 1 of monlunabant treatment
Group IV: Placebo (monlunabant)Placebo Group1 Intervention
Placebo treatment

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,541 Previous Clinical Trials
2,440,998 Total Patients Enrolled
151 Trials studying Obesity
143,290 Patients Enrolled for Obesity
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
123 Previous Clinical Trials
151,486 Total Patients Enrolled
36 Trials studying Obesity
50,682 Patients Enrolled for Obesity
~36 spots leftby Oct 2024
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