A Research Study Looking at How the Medicine NNC0385-0434 Works in the Body of Healthy Japanese Men

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers; Atherosclerotic Cardiovascular Disease

Treatments: Drug: NNC0385-0434; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05003440

jRCT2071210055 (Registry Identifier)

NN6435-4748

U1111-1264-4546 (Other Identifier)

Details and patient eligibility

About

The aim of this study is to look at how the study medicine works in the body and how it is removed from the body.

We are testing the study medicine to make a medicine that can help people lower their cholesterol level.

Participants will either get

1. NNC0385-0434 (a potential new medicine) in one of three different doses: 15 mg, 40 mg, or 100 mg.
2. placebo (a dummy medicine which looks like the study medicine but without any medicine).

Which treatment participants get is decided by chance. NNC0385-0434 is a new medicine and has not been approved by the Health Authorities (Centre for Drug Evaluation).

Participants will get 1 tablet per day for 10 days. The tablet will be handed out by a study doctor or site staff at the clinic and the study will last between 62 and 98 days.

Participants will have 7 clinic visits. One of these visits will be a 13-day, 12-night stay (V2) and the rest will be 1-day visits (V1 and V3 to V7).

At all visits, except the information visit, participants will have blood drawn along with other clinical checks.

Participants will be asked about their health, medical history and habits including mental health.

Enrollment: 36 patients

Sex: Male

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body weight greater than or equal to 54.0 kg.
• Body mass index (BMI) between 20.0 and 34.9 kg/m^2 (both inclusive).

Exclusion criteria

• Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator.
• Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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36 participants in 6 patient groups, including a placebo group

NNC0385-0434 15 mg

Experimental group

Description:

15 mg oral NNC0385-0434 will be administered once-daily over 10 consecutive days

Treatment:

Drug: NNC0385-0434

Placebo (NNC0385-0434 15 mg)

Placebo Comparator group

Description:

Oral placebo will be administered once-daily over 10 consecutive days

Treatment:

Drug: Placebo

NNC0385-0434 40 mg

Experimental group

Description:

40 mg oral NNC0385-0434 will be administered once-daily over 10 consecutive days

Treatment:

Drug: NNC0385-0434

Placebo (NNC0385-0434 40 mg)

Placebo Comparator group

Description:

Oral placebo will be administered once-daily over 10 consecutive days

Treatment:

Drug: Placebo

NNC0385-0434 100 mg

Experimental group

Description:

100 mg oral NNC0385-0434 will be administered once-daily over 10 consecutive days

Treatment:

Drug: NNC0385-0434

Placebo (NNC0385-0434 100 mg)

Placebo Comparator group

Description:

Oral placebo will be administered once-daily over 10 consecutive days

Treatment:

Drug: Placebo