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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: Semaglutide

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Novo Nordisk; Phone Number: (+1) 866-867-7178; Email: clinicaltrials@novonordisk.com

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3P 3P1
      • Recruiting
      • Altasciences Clinical Company, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2023
• Primary Completion (Estimated): March 24, 2024
• Study Completion (Estimated): March 24, 2024

Study Registration Dates

• First Submitted: October 18, 2023
• First Submitted That Met QC Criteria: October 18, 2023
• First Posted (Actual): October 24, 2023

Study Record Updates

• Last Update Posted (Estimated): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: NN9501-4924; U1111-1289-1040 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No