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OpenTrials
Completed

NCT Number: NCT06642584

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

This study is conducted to compare four different tablets containing the investigational medicine semaglutide at the same dose. It is done to test how semaglutide in each of the tablet versions is taken up in the body. Which treatments participants will receive is decided by chance. The study will last for about 28 weeks. The study will enroll healthy male participants.

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Key information

Conditions

Healthy Volunteers Type 2 Diabetes

Age range

18 year–64 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Altasciences

Montreal, Quebec, H3P 3P1, Canada

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male.
  • Age 18-64 years (both inclusive) at the time of signing the informed consent.
  • Body mass index (BMI) between 22.0 and 31.9 kilogram per square meter (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 (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Exclusion criteria

  • Known or suspected hypersensitivity to study interventions or related products.
  • Any condition 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 prior to first dosing.

Treatment and study plan

Semaglutide B

Drug

Semaglutide B will be administered subcutaneously.

Semaglutide J

Drug

Semaglutide J will be administered as oral tablets.

Semaglutide L

Drug

Semaglutide L will be administered as oral tablets.

Semaglutide M

Drug

Semaglutide M will be administered as oral tablets.

Semaglutide N

Drug

Semaglutide N will be administered as oral tablets.

Primary outcomes

  1. Adjusted AUC(sema); adjusted area under the semaglutide plasma concentration-time curve

    Time frame: From 0 to 24 hours after dosing on Days 122 and 132.

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

  2. Adjusted Cmax,(sema); adjusted maximum observed semaglutide plasma concentration

    Time frame: From 0 to 24 hours after dosing on Days 122 and 132.

    Measured in nanomoles per liter(nmol/L).

  3. Adjusted tmax,sema; time to adjusted maximum observed semaglutide plasma concentration

    Time frame: From 0 to 24 hours after dosing on Days 122 and 132.

    Measured in hours.

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

    Time frame: From 0 to 840 hours after dosing on Day 132.

    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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 15, 2024
Registry last updated
Oct 20, 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.

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