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

Sponsor
Novo Nordisk A/S
Study ID
NCT06097390
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Participants

Eligibility Criteria

Sex
MALE
Age
18 Years - 64 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

Start date
Sep 28, 2023
Status verified
Jul 2025
Primary completion
Feb 22, 2024
Completion
Mar 27, 2024

Study Design

Enrollment
121 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

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 ]

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