Trial Investigating the Absorption, Metabolism and Excretion After a Single Subcutaneous Dose of [3H]-Semaglutide in Healthy Male Subjects

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of the trial is to investigate the absorption, metabolism and excretion after a single subcutaneous dose of [3H]-semaglutide in healthy male subjects.

Official Title
-----------------
A Single Centre, Open Label Trial Investigating the Absorption, Metabolism and Excretion After a Single Subcutaneous Dose of [3H]-Semaglutide in Healthy Male Subjects

Conditions
-----------------
Diabetes, Healthy

Intervention / Treatment
-----------------
* Drug: semaglutide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male subjects, based on an assessment of medical history, physical examination, ECG (electrocardiogram) and vital signs, as determined by the investigator Age between 45-64 years (both inclusive) at the time of signing inform consent Body mass index (BMI) between 20 and 30 kg/m^2 (both inclusive) Exclusion Criteria: Donation of any blood or plasma in the past month or in excess of 100 mL within the 3 months preceding screening, or surgery or trauma with more than 100 mL blood loss within the 3 months preceding screening Use of prescription or non-prescription systemic or topical medicinal products (except routine vitamins, acetylsalicylic acid and paracetamol) within 3 weeks (or within 5 half-lives of the medicinal product, whichever is longest) prior to visit 2, Day 1 History of drug/chemical substance abuse within 1 year from screening, or a positive result in the urine drug test History of alcohol abuse within 1 year from screening, or a positive result in the alcohol urine test, or consumption of more than 21 units of alcohol weekly (one unit of alcohol equals about 250 mL of beer or lager, one glass (120 mL) of wine, or 20 mL spirits) Smoking or use of any nicotine (including nicotine patches, gum, etc) in the last 3 months prior to screening or a positive nicotine test

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 64 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Semaglutide<br> | Drug: semaglutide<br>* Subjects will receive a single dose subcutaneously (s.c., under the skin).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of the major metabolites of [3H]-semaglutide in plasma, urine, and faeces |  | Up to 9 weeks following a single dose of 0.5 mg [3H]-semaglutide | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total amount of [3H]-semaglutide related material excreted in urine (% of dose) |  | Up to 9 weeks following a single dose of 0.5 mg [3H]-semaglutide | 
| Total amount of [3H]-semaglutide related material excreted in faeces (% of dose) |  | Up to 9 weeks following a single dose of 0.5 mg [3H]-semaglutide | 
| Blood to plasma ratio of [3H]-semaglutide related material |  | Up to 9 weeks following a single dose of 0.5 mg [3H]-semaglutide | 
| Area under the semaglutide plasma concentration curve |  | From time 0 until infinity after a single dose | 
| Maximum observed semaglutide plasma concentration |  | After a single dose |