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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers; High Cholesterol

Treatments: Drug: NNC0385-0434 B; Drug: NNC0385-0434 G; Drug: NNC0385-0434 F

Study type: Interventional

Funder types: Industry

Identifiers

NCT05333107

NN9501-4869

U1111-1271-3953 (Other Identifier)

Details and patient eligibility

About

In this study, the study drug 'NNC0385-0434' will be tested in 3 different tablet formulations. These formulations are being tested for the treatment of hypercholesterolemia (high cholesterol). Participants will only receive 2 of the 3 tablet formulations. The treatments participants get are decided by chance. Participants will receive 1 formulation for 10 days (first treatment period) and the other formulation for 5 days (second treatment period). The study will last up to 96 days. Only men can participate in this clinical study.

Enrollment: 152 patients

Sex: Male

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male
• Aged 18-64 years (both inclusive) at the time of signing informed consent
• Body mass index between 20.0 and 32.0 kilogram per meter square (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 of major surgical procedures involving the stomach potentially affecting absorption of study products (example: subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

152 participants in 6 patient groups

Sequence 1

Experimental group

Description:

Participants will receive oral dose of NNC0385-0434 G tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 B tablet orally in the 5-day treatment period (period 2).

Treatment:

Drug: NNC0385-0434 G

Drug: NNC0385-0434 B

Sequence 2

Experimental group

Description:

Participants will receive oral dose of NNC0385-0434 G tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 F tablet orally in the 5-day treatment period (period 2).

Treatment:

Drug: NNC0385-0434 F

Drug: NNC0385-0434 G

Sequence 3

Experimental group

Description:

Participants will receive oral dose of NNC0385-0434 F tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 B tablet orally in the 5-day treatment period (period 2).

Treatment:

Drug: NNC0385-0434 F

Drug: NNC0385-0434 B

Sequence 4

Experimental group

Description:

Participants will receive oral dose of NNC0385-0434 F tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 G tablet orally in the 5-day treatment period (period 2).

Treatment:

Drug: NNC0385-0434 F

Drug: NNC0385-0434 G

Sequence 5

Experimental group

Description:

Participants will receive oral dose of NNC0385-0434 B tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 G tablet orally in the 5-day treatment period (period 2).

Treatment:

Drug: NNC0385-0434 G

Drug: NNC0385-0434 B

Sequence 6

Experimental group

Description:

Participants will receive oral dose of NNC0385-0434 B tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 F tablet orally in the 5-day treatment period (period 2).

Treatment:

Drug: NNC0385-0434 F

Drug: NNC0385-0434 B