Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NN9924 in Healthy Male Subjects

Study Overview
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Brief Summary
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This trial is conducted in Europe. The aim of the trial is to investigate safety, tolerability, pharmacokinetics (the rate at which the body eliminates the trial drug) and pharmacodynamics (the effect of the investigated drug on the body) of NN9924 in healthy male subjects

Official Title
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Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of a Long-acting GLP-1 Analogue in Healthy Male Subjects

Conditions
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Diabetes, Diabetes Mellitus, Type 2, Healthy

Intervention / Treatment
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* Drug: semaglutide
* Drug: placebo
* Drug: semaglutide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male subjects, based on an assessment of medical history, physical examination and BMI between 21 and 30 kg/m2 (21 inclusive) Exclusion Criteria: Male subjects who are sexually active and unwilling to use a highly effective method of contraception for both them and their nonpregnant partner Any clinically significant, abnormal disease history of the following systems: cardio-pulmonary, gastrointestinal, hepatic, neurological, renal,genitourinary, endocrine or haematological The receipt of any investigational product within 90 days before screening, or is currently enrolled in any other clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral 1<br> | Drug: semaglutide<br>* Semaglutide (oral) administered once daily for 10 weeks.Individually adjusted dose investigated up to maximum level.<br>Drug: placebo<br>* Placebo (oral) administered once daily for 10 weeks.<br>|
| Experimental: Oral 2<br> | Drug: semaglutide<br>* Semaglutide (oral) administered once daily for 10 weeks.Individually adjusted dose investigated up to maximum level.<br>Drug: placebo<br>* Placebo (oral) administered once daily for 10 weeks.<br>|
| Experimental: Oral 3<br> | Drug: semaglutide<br>* Semaglutide (oral) administered once daily for 10 weeks.Individually adjusted dose investigated up to maximum level.<br>Drug: placebo<br>* Placebo (oral) administered once daily for 10 weeks.<br>|
| Active Comparator: S.c.<br> | Drug: semaglutide<br>* Administered s.c. (under the skin) once weekly for 10 weeks. Individually adjusted dose investigated up to maximum level.<br>* Other names: NN9924;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of adverse events (AEs) |  | from the first trial related activity (screening visit) and until completion of the post treatment follow-up visit 91-105 days after first dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoglycaemic episodes |  | from the first trial related activity (screening visit) and until completion of the post treatment follow-up visit 91-105 days after first dose | 
| Laboratory safety variables (haematology, biochemistry, and urinalysis) |  | from the first trial related activity (screening visit) and until completion of the post treatment follow-up visit 91-105 days after first dose | 
| Maximum plasma concentration of NN9924 |  | after dosing on the 68th, 69th and 70th Day | 
| Area under the plasma concentration curve over the dosing interval (0-24 hours) |  | after dosing on the 68th, 69th and 70th day | 
| Terminal phase elimination half-life |  | from last dose (day 70) to follow-up visit 91-105 days after first dose |