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

Last updated: November 18, 2024
Sponsor: Novo Nordisk A/S
Overall Status: Active - Recruiting

Phase

1

Condition

N/A

Treatment

Semaglutide J

Semaglutide B

Semaglutide N

Clinical Study ID

NCT06642584
NN9501-5006
U1111-1304-9627
  • Ages 18-64
  • Male
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male.

  2. Age 18-64 years (both inclusive) at the time of signing the informed consent.

  3. Body mass index (BMI) between 22.0 and 31.9 kilogram per square meter (kg/m^2) (bothinclusive) at screening.

  4. Considered to be generally healthy based on the medical history, physicalexamination, and the results of vital signs, electrocardiogram (ECG) and clinicallaboratory tests performed during the screening visit, as judged by theinvestigator.

Exclusion

Exclusion Criteria:

  1. Known or suspected hypersensitivity to study interventions or related products.

  2. Any condition which in the investigator's opinion might jeopardise participant'ssafety or compliance with the protocol.

  3. Use of prescription medicinal products or non-prescription drugs, except routinevitamins, topical medication not reaching the systemic circulation and occasionaluse of paracetamol (acetaminophen) and ibuprofen, within 14 days prior to firstdosing.

Study Design

Total Participants: 90
Treatment Group(s): 5
Primary Treatment: Semaglutide J
Phase: 1
Study Start date:
October 15, 2024
Estimated Completion Date:
May 25, 2025

Connect with a study center

  • Altasciences

    Montreal, Quebec H3P 3P1
    Canada

    Active - Recruiting

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