A Research Study Comparing the Effect of Different Dosing Conditions on Blood Levels of Semaglutide in a New Tablet Composition in Healthy Participants

Phase

Condition

N/A

Treatment

Semaglutide

Clinical Study ID

NCT05996874

NN9924-4977

U1111-1281-4819

2022-002848-52

Ages 18-64
Male
Accepts Healthy Volunteers

Study Summary

In this study, a known medicine called 'semaglutide' will be tested in a new tablet version. The medicine will be tested in healthy men to explore the effect of different water volumes and tablet-meal delays on blood levels of semaglutide after 10 days of oral administration. Semaglutide tablets, under the brand name Rybelsus, are approved in the EU and USA for the treatment of type 2 diabetes. Participants will get a daily treatment with dose 1 new oral semaglutide tablet for 5 days followed by another 5 days with a daily treatment of dose 2 new oral semaglutide tablet. Participants will get one tablet each day for 10 days. The tablet should be taken in the morning on an empty stomach with either 50 milliliter (mL) or 120mL water, after an overnight fast of at least 6 hours (no food or drinks). Water is not allowed from 2 hours before dosing. A predefined breakfast will be served either 30, 60 or 120 minutes after taking tablet, depending on the treatment received. Breakfast will need to be eaten within 30 minutes. Which treatment participants will get is decided by chance. The study will last for about 11 weeks. This will include a screening period (up to 28 days), a treatment period (10 days) and a follow-up visit (at least 5 weeks after the last dose). Participants should not take any prescription or non-prescription medicines or herbal products (including St John's wort) within 14 days prior to the screening visit and until the follow-up visit, except for routine vitamins, medicines applied on the skin and occasional use of paracetamol (a mild pain killer). No oral medication can be taken from 2 hours before and, depending on the group participants are in, until 30, 60 or 120 minutes after each dosing with semaglutide.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Body mass index (BMI) between 18.5 and 29.9 kilograms per meter square (kg/m^2) (both inclusive)
Considered to be generally healthy based on the medical history, physicalexamination, and the results of vital signs, electrocardiogram and clinicallaboratory tests performed during the screening visit, as judged by the investigator

Exclusion

Exclusion Criteria:

Glycated Hemoglobin (HbA1c) greater than or equal to (>=) 6.5 percent (%) (48millimoles per mole [mmol/mol]) at screening
Use of tobacco and nicotine products, defined as any of the below:

Smoking more than 5 cigarettes or the equivalent per day
Not willing to refrain from smoking and use of nicotine substitute productswithin 48 hours prior to and during the inpatient periods

Presence of clinically significant gastrointestinal disorders potentially affectingabsorption of drugs and/or nutrients, as judged by the investigator
Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2or medullary thyroid carcinoma
History of major surgical procedures involving the stomach potentially affectingabsorption of trial products (e.g. subtotal and total gastrectomy, sleevegastrectomy, gastric bypass surgery) or current presence of gastrointestinal implant

Study Design

Semaglutide

August 12, 2023

April 18, 2024

Connect with a study center

Novo Nordisk Investigational Site
Neuss, 41460
Germany
Active - Recruiting
Profil Institut für Stoffwechselforschung GmbH
Neuss, 41460
Germany
Site Not Available

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