A Research Study Looking at New Protein-based Tablets in Healthy Men - Oral Formulation III

Study Overview
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Brief Summary
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In this study, a known medicine called 'semaglutide' will be tested in two different tablet versions. The two tablets differ in the way these have been manufactured. The aim of the study is to investigate the amount of active ingredient in the blood after dosing the different tablet versions. Participants will receive one tablet version for 10 days (first treatment period) and the other version for 10 days (second treatment period). The treatment arm participants will be assigned to is decided by chance. The study will last for about 22 weeks for each participant. The study will enroll healthy male participants.

Official Title
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A Study Investigating the Pharmacokinetic Properties When Dosing Different Formulations of Semaglutide to Healthy Male Participants - Oral Formulation III

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: Semaglutide


Participation Criteria
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Eligibility Criteria
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Key inclusion criteria: Body mass index (BMI) between 22.0 and 31.9 kilograms per meter square (kg/m^2) (both inclusive) at screening. Considered to be generally healthy 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. Key exclusion criteria: Known or suspected hypersensitivity to study intervention(s) or related products. Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol. Use of prescription medicinal products or non-prescription drugs, except routine vitamins, topical medication not reaching the systemic circulation and occasional use of paracetamol (acetaminophen) and ibuprofen, within 14 days before screening.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence 1: Semaglutide J then Semaglutide K<br>Oral semaglutide J will be administered in treatment period 1 followed by semaglutide K in treatment period 2. | Drug: Semaglutide<br>* Oral administration<br>|
| Experimental: Sequence 2: Semagultide K then Semaglutide J<br>Oral semaglutide K will be administered in treatment period 1 followed by semaglutide J in treatment period 2. | Drug: Semaglutide<br>* Oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adjusted AUC0-24h,sema; adjusted area under the semaglutide plasma concentration-time curve | Measured in hour*nanomoles per liter (h*nmol/L). | From 0 to 24 hours after dosing on day 80 and 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adjusted Cmax,0-24h,sema; adjusted maximum observed semaglutide plasma concentration | Measured in nanomoles per liter (nmol/L). | From 0 to 24 hours after dosing on day 80 and 90 | 
| Adjusted tmax,0-24h,sema; time to adjusted maximum observed semaglutide plasma concentration | Measured in hours. | From 0 to 24 hours after dosing on day 80 and 90 | 
| t½,sema; the terminal half-life of semaglutide | Measured in hours. | From 0 to 840 hours after dosing on day 90 |