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

Healthy Participants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06097390
• Other study ID #: NN9501-4924
• Secondary ID: U1111-1289-1040
• Status: Completed
• Phase: Phase 1
• Start date: September 28, 2023
• Est. completion date: March 27, 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 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 23 weeks for each participant. The study will enroll healthy male participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: March 27, 2024
• Est. primary completion date: February 22, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• Semaglutide
Oral administration

Locations

Country	Name	City	State
Canada	Altasciences Clinical Company, Inc	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	t½,sema; the terminal half-life of semaglutide	Measured in hours.	From 0 to 840 hours after dosing on day 90