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

Healthy Participants Clinical Trial

Official title:

Investigation of the Effect of Dosing Conditions on the Pharmacokinetics of New Oral Semaglutide Formulation in Healthy Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05996874
• Other study ID #: NN9924-4977
• Secondary ID: U1111-1281-48192
• Status: Completed
• Phase: Phase 1
• Start date: August 12, 2023
• Est. completion date: April 18, 2024

Study information

• Verified date: May 2024
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: April 18, 2024
• Est. primary completion date: April 18, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 64 Years

Eligibility

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, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator

Exclusion Criteria:

• Glycated Hemoglobin (HbA1c) greater than or equal to (>=) 6.5 percent (%) (48 millimoles per mole [mmol/mol]) at screening

• Use of tobacco and nicotine products, defined as any of the below:

1. Smoking more than 5 cigarettes or the equivalent per day

2. Not willing to refrain from smoking and use of nicotine substitute products within 48 hours prior to and during the inpatient periods

• Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator

• Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma

• History of major surgical procedures involving the stomach potentially affecting absorption of trial products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery) or current presence of gastrointestinal implant

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• Semaglutide
Participants will receive Dose 1 oral semaglutide D for the first 5 days followed by Dose 2 of oral semaglutide D for another 5 days.

Locations

Country	Name	City	State
Germany	Profil Institut für Stoffwechselforschung GmbH	Neuss

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC0-24h,sema,Day10: Area under the semaglutide plasma concentration-time curve during a dosing interval after the 10th dosing	Measured in hour*nanomoles per liter (h*nmol/L).	From 0 to 24 hours after dosing on day 10
Secondary	Cmax,0-24h,sema,Day10: Maximum semaglutide plasma concentration after the 10th dosing	Measured in nanomoles per liter (nmol/L).	From 0 to 24 hours after dosing on day 10
Secondary	tmax,0-24h,sema,Day10: Time to maximum semaglutide plasma concentration after the 10th dosing	Measured in hours (h).	From 0 to 24 hours after dosing on day 10