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

Phase 1

Completed

• Conditions: Healthy Participants
• Interventions: Drug: Semaglutide

• Registration Number: NCT06097390
• Lead Sponsor: Novo Nordisk A/S

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-28
• Study First Submitted: 2023-10-18
• Study First Submitted QC: 2023-10-18
• Study First Posted: 2023-10-24
• Primary Completion: 2024-02-22
• Study Completion: 2024-03-27
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-18
• Last Update Posted: 2024-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 121

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 2: Semagultide K then Semaglutide J	Semaglutide	Oral semaglutide K will be administered in treatment period 1 followed by semaglutide J in treatment period 2.
Sequence 1: Semaglutide J then Semaglutide K	Semaglutide	Oral semaglutide J will be administered in treatment period 1 followed by semaglutide K in treatment period 2.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).
t½,sema; the terminal half-life of semaglutide	From 0 to 840 hours after dosing on day 90	Measured in hours.
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.

Trial Locations

Locations (1)

Altasciences Clinical Company, Inc; 🇨🇦 Montreal, Quebec, Canada