A Research Study Looking at New Protein-based Tablets in Healthy Male Participants

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers; Type 2 Diabetes; High Blood Cholesterol Levels

Treatments: Drug: NNC0385-0434 E; Drug: Semaglutide H; Drug: NNC0385-0434 D; Drug: Semaglutide I; Drug: NNC0385-0434 C; Drug: NNC0385-0434 B; Drug: Semaglutide D; Drug: Semaglutide G

Study type: Interventional

Funder types: Industry

Identifiers

NCT05129891

2021-001452-34 (EudraCT Number)

U1111-1266-0672 (Other Identifier)

NN9501-4821

Details and patient eligibility

About

In this study, four new tablet versions of two compounds will be investigated.

The aim of this study is to investigate the amount of the active ingredient and helping agent in the blood after doses of four different tablet versions. The tablet versions, participants will receive, i.e. the treatment arm participants will be assigned to, is decided by chance.

Participants will receive one treatment for 10 days in the first period. For the second period, directly following, participants will receive a different treatment for five more days.

The study can last for up to approximately 10 weeks for each participant. This includes a screening period (up to 3 weeks), two treatment periods (together a total of 15 days) and a follow-up visit (5 weeks after the last dosing)

Enrollment: 384 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male.
• Aged 18-55 years (both inclusive) at the time of signing informed consent.
• Body mass index 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

• Known or suspected hypersensitivity to study interventions or related products.
• Use of prescription medicinal products or non-prescription drugs (including herbal products and vaccines), except routine vitamins and topical medications not reaching the systemic circulation, within 14 days prior to the day of screening.
• Any disorder which in the investigator's opinion might jeopardise participant safety or compliance with the protocol.
• Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator.
• History (as declared by the participant or reported in the medical records) of major surgical procedures involving the stomach potentially affecting absorption of study products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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384 participants in 2 patient groups

Part A: Oral semaglutide

Experimental group

Description:

Four different formulations of oral semaglutide are investigated. One formulation given for 10 days before participants receive a different formulation for 5 days

Treatment:

Drug: Semaglutide G

Drug: Semaglutide D

Drug: Semaglutide I

Drug: Semaglutide H

Part B: NNC0385-0434

Experimental group

Description:

Four different formulations of NNC0385-0434 are investigated. One formulation given for 10 days before participants receive a different formulation for 5 days

Treatment:

Drug: NNC0385-0434 B

Drug: NNC0385-0434 C

Drug: NNC0385-0434 D

Drug: NNC0385-0434 E