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

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT06097390
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 5.8
• Patients Per Site Per Month: 20.5

Study Details

Study Description

Brief 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 22 weeks for each participant. The study will enroll healthy male participants.

Condition or Disease	Intervention/Treatment	Phase
Healthy Participants	Drug: Semaglutide	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Study Investigating the Pharmacokinetic Properties When Dosing Different Formulations of Semaglutide to Healthy Male Participants - Oral Formulation III
• Actual Study Start Date: Sep 28, 2023
• Anticipated Primary Completion Date: Mar 24, 2024
• Anticipated Study Completion Date: Mar 24, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Adjusted AUC0-24h,sema; adjusted area under the semaglutide plasma concentration-time curve [From 0 to 24 hours after dosing on day 80 and 90]

   Measured in hour*nanomoles per liter (h*nmol/L).

Secondary Outcome Measures

1. Adjusted Cmax,0-24h,sema; adjusted maximum observed semaglutide plasma concentration [From 0 to 24 hours after dosing on day 80 and 90]

   Measured in nanomoles per liter (nmol/L).

2. Adjusted tmax,0-24h,sema; time to adjusted maximum observed semaglutide plasma concentration [From 0 to 24 hours after dosing on day 80 and 90]

   Measured in hours.

3. t½,sema; the terminal half-life of semaglutide [From 0 to 840 hours after dosing on day 90]

   Measured in hours.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Montreal	Quebec	Canada	H3P 3P1

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT06097390
• Other Study ID Numbers: NN9501-4924; U1111-1289-1040
• First Posted: Oct 24, 2023
• Last Update Posted: Oct 24, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Oct 24, 2023