Clinical trial

A Study Investigating the Pharmacokinetic Properties When Dosing Different Formulations of NNC0385-0434 to Healthy Male Participants - Oral Formulation II

Name

NN9501-4869

Description

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.

Trial arms

Trial start

2022-04-12

Estimated PCD

2022-07-22

Trial end

2022-09-23

Status

Completed

Phase

Early phase I

Treatment

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).

Arms:

Sequence 1, Sequence 2, Sequence 4, Sequence 5

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).

Arms:

Sequence 2, Sequence 3, Sequence 4, Sequence 6

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).

Arms:

Sequence 1, Sequence 3, Sequence 5, Sequence 6

Size

152

Primary endpoint

AUC0-24h,NNC0385-0434,day10; area under the plasma concentrationtime curve during a dosing interval

From 0 to 24 hours after dose administration on visit 2, day 10

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)

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 152, 'type': 'ACTUAL'}}

Updated at

2023-07-10

1 organization

2 products

1 indication

Organization

Product

Indication

Product