Research Study Comparing Different Tablets With the Study Medicine Semaglutide in Healthy Men

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Semaglutide B 3 mg; Drug: Semaglutide 7 mg; Drug: Semaglutide C 7 mg; Drug: Semaglutide 3 mg; Drug: Semaglutide B 7 mg; Drug: Semaglutide D 7 mg; Drug: Semaglutide C 3 mg; Drug: Semaglutide D 3 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03638778

U1111-1206-6210 (Other Identifier)

2017-005023-24 (Registry Identifier)

NN9924-4427

Details and patient eligibility

About

This study looks at different tablets with a new study medicine called semaglutide. It is to treat diabetes. The aim of the study is to find out how much study medicine from 4 different tablets is taken up in the body. Participants will either get semaglutide in the tablet currently being studied in large studies, or 1 of the 3 new tablets that also contains 'semaglutide' - which treatment participants get is decided by chance. The tablet version of study medicine is a new medicine that cannot be prescribed. Semaglutide can be prescribed as injections for the treatment of diabetes in some countries. Participants will get 1 tablet per day for 10 days. The tablets should be taken in the morning by mouth together with half a glass of water. After dosing participants have to wait 30 minutes before participants may eat or drink. The study will last up to 70 days. Participants will have 17 clinic visits with the study doctor. Some of the visits are overnight stays. Participants will have blood tests at every visit.

Enrollment: 105 patients

Sex: Male

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: - Male, aged 18-64 years (both inclusive) at the time of signing informed consent. - Body mass index (BMI) between 20.0 and 29.9 kg/m^2 (both inclusive). - 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. Exclusion Criteria: - Glycated haemoglobin (HbA1c) greater than or equal to 6.5% (48 mmol/mol) at screening. - Use of tobacco and nicotine products, defined as any of the below: a) Smoking more than 5 cigarettes or the equivalent per day. b) Not willing to refrain from smoking and use of nicotine substitute products during the in-house period(s). - History* of major surgical procedures involving the stomach potentially affecting absorption of trial products (e.g., subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery). - Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or nutrients, as judged by the investigator. - Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma*. - History* or presence of pancreatitis (acute or chronic). *As declared by subject.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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105 participants in 4 patient groups

Oral semaglutide (reference)

Active Comparator group

Description:

Participants will receive oral semaglutide (reference) for 10 days.

Treatment:

Drug: Semaglutide 3 mg

Drug: Semaglutide 7 mg

Oral semaglutide formulation B

Experimental group

Description:

Participants will receive oral semaglutide formulation B for 10 days.

Treatment:

Drug: Semaglutide B 7 mg

Drug: Semaglutide B 3 mg

Oral semaglutide formulation C

Experimental group

Description:

Participants will receive oral semaglutide formulation C for 10 days.

Treatment:

Drug: Semaglutide C 3 mg

Drug: Semaglutide C 7 mg

Oral semaglutide formulation D

Experimental group

Description:

Participants will receive oral semaglutide formulation D for 10 days.

Treatment:

Drug: Semaglutide D 3 mg

Drug: Semaglutide D 7 mg