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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Semaglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT06097390

U1111-1289-1040 (Other Identifier)

NN9501-4924

Details and patient eligibility

About

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.

Enrollment: 121 patients

Sex: Male

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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121 participants in 2 patient groups

Sequence 1: Semaglutide J then Semaglutide K

Experimental group

Description:

Oral semaglutide J will be administered in treatment period 1 followed by semaglutide K in treatment period 2.

Treatment:

Drug: Semaglutide

Sequence 2: Semagultide K then Semaglutide J

Experimental group

Description:

Oral semaglutide K will be administered in treatment period 1 followed by semaglutide J in treatment period 2.

Treatment:

Drug: Semaglutide