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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-19

Study Completion Date

2022-01-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Research Study Investigating How NNC0385-0434 is Tolerated in People With or Without High Cholesterol Levels

NCT04058834

Healthy Volunteers Hypercholesterolaemia

COMPLETED PHASE1

A Research Study Looking at the Effect of Food Intake on How the Medicine NN0385-0434 Behaves in the Body of Healthy Participants

NCT05091073

Established Atherosclerotic Cardiovascular Disease (ASCVD) or ASCVD Risk Elevated Cholesterol Healthy Volunteers

COMPLETED PHASE1

the Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects in Adult Subjects With Elevated LDL-C

NCT06132360

To Reduce the LDL-C Level in Hypercholesteremia Patients

COMPLETED PHASE1

A Research Study Looking at How NNC0385-0434 Tablets Work to Lower Blood Cholesterol in People With Heart Disease or a High Risk of Heart Disease

NCT04992065

Atherosclerotic Cardiovascular Disease

COMPLETED PHASE2

A Study of LY3015014 in Healthy Participants With Elevated Low Density Lipoprotein Cholesterol

NCT01426412

Hyperlipidemia

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Volunteers Atherosclerotic Cardiovascular Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

The study consists of two parts. Part 1 consists of three sequential dose ascension cohorts each with 4 healthy Japanese participants, randomised 3:1. The purpose of Part 1 is to provide safety clearance for initiating Part 2 and the randomisation of Japanese participants into the phase 2 study NN6435-4697. Part 2 will randomise the remaining Japanese participants into three parallel dose groups. (3:1:3:1:3:1).

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

NNC0385-0434 15 mg

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

Group Type EXPERIMENTAL

NNC0385-0434

Intervention Type DRUG

Participants will get 1 tablet (oral use) of NNC0385-0434 per day for 10 days in either 15, 40 or 100 mg

Placebo (NNC0385-0434 15 mg)

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Participants will get 1 tablet (oral use) of placebo per day for 10 days

NNC0385-0434 40 mg

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

Group Type EXPERIMENTAL

NNC0385-0434

Intervention Type DRUG

Participants will get 1 tablet (oral use) of NNC0385-0434 per day for 10 days in either 15, 40 or 100 mg

Placebo (NNC0385-0434 40 mg)

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Participants will get 1 tablet (oral use) of placebo per day for 10 days

NNC0385-0434 100 mg

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

Group Type EXPERIMENTAL

NNC0385-0434

Intervention Type DRUG

Participants will get 1 tablet (oral use) of NNC0385-0434 per day for 10 days in either 15, 40 or 100 mg

Placebo (NNC0385-0434 100 mg)

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Participants will get 1 tablet (oral use) of placebo per day for 10 days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

NNC0385-0434

Participants will get 1 tablet (oral use) of NNC0385-0434 per day for 10 days in either 15, 40 or 100 mg

Intervention Type DRUG

Placebo

Participants will get 1 tablet (oral use) of placebo per day for 10 days

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes