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

NCT ID: NCT05333107

Last Updated: 2024-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-12
• Study Completion Date: 2022-09-23

Brief Summary

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.

Conditions

Healthy Volunteers; High Cholesterol

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sequence 1

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).

Group Type: EXPERIMENTAL

NNC0385-0434 G

Intervention Type: DRUG

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

NNC0385-0434 B

Intervention Type: DRUG

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

Sequence 2

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).

Group Type: EXPERIMENTAL

NNC0385-0434 G

Intervention Type: DRUG

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

NNC0385-0434 F

Intervention Type: DRUG

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

Sequence 3

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).

Group Type: EXPERIMENTAL

NNC0385-0434 F

Intervention Type: DRUG

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

NNC0385-0434 B

Intervention Type: DRUG

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

Sequence 4

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).

Group Type: EXPERIMENTAL

NNC0385-0434 G

Intervention Type: DRUG

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

NNC0385-0434 F

Intervention Type: DRUG

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

Sequence 5

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).

Group Type: EXPERIMENTAL

NNC0385-0434 G

Intervention Type: DRUG

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

NNC0385-0434 B

Intervention Type: DRUG

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

Sequence 6

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).

Group Type: EXPERIMENTAL

NNC0385-0434 F

Intervention Type: DRUG

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

NNC0385-0434 B

Intervention Type: DRUG

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

Interventions

NNC0385-0434 G

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

Intervention Type: DRUG

NNC0385-0434 F

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

Intervention Type: DRUG

NNC0385-0434 B

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

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Transparency dept. 2834

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Altasciences

Cypress, California, United States

Altasciences Clinical Los Angeles, Inc.

Los Angeles, California, United States

Countries

United States

Other Identifiers

U1111-1271-3953

Identifier Type: OTHER

Identifier Source: secondary_id

NN9501-4869

Identifier Type: -

Identifier Source: org_study_id