Skip to main content
OpenTrials
Completed

NCT Number: NCT06097390

A Research Study Looking at New Protein-based Tablets in Healthy Men - 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Participants

Age range

18 year–64 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Altasciences Clinical Company, Inc

Montreal, Quebec, H3P 3P1, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

semaglutide

Drug

Oral administration

Primary outcomes

  1. Adjusted AUC0-24h,sema; adjusted area under the semaglutide plasma concentration-time curve

    Time frame: From 0 to 24 hours after dosing on day 80 and 90

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

Secondary outcomes

  1. Adjusted Cmax,0-24h,sema; adjusted maximum observed semaglutide plasma concentration

    Time frame: 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

    Time frame: From 0 to 24 hours after dosing on day 80 and 90

    Measured in hours.

  3. t½,sema; the terminal half-life of semaglutide

    Time frame: From 0 to 840 hours after dosing on day 90

    Measured in hours.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 24, 2023
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.