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

Study Overview
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Brief Summary
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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 NNC0385-0434 (a potential new medicine) in one of three different doses: 15 mg, 40 mg, or 100 mg. 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.

Official Title
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Investigation of Safety, Tolerability and Pharmacokinetic Properties of Multiple Doses of Oral NNC0385-0434 in Healthy, Male Japanese Participants

Conditions
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Healthy Volunteers, Atherosclerotic Cardiovascular Disease

Intervention / Treatment
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* Drug: NNC0385-0434
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: 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).
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NNC0385-0434 15 mg<br>15 mg oral NNC0385-0434 will be administered once-daily over 10 consecutive days | Drug: NNC0385-0434<br>* Participants will get 1 tablet (oral use) of NNC0385-0434 per day for 10 days in either 15, 40 or 100 mg<br>|
| Placebo Comparator: Placebo (NNC0385-0434 15 mg)<br>Oral placebo will be administered once-daily over 10 consecutive days | Drug: Placebo<br>* Participants will get 1 tablet (oral use) of placebo per day for 10 days<br>|
| Experimental: NNC0385-0434 40 mg<br>40 mg oral NNC0385-0434 will be administered once-daily over 10 consecutive days | Drug: NNC0385-0434<br>* Participants will get 1 tablet (oral use) of NNC0385-0434 per day for 10 days in either 15, 40 or 100 mg<br>|
| Placebo Comparator: Placebo (NNC0385-0434 40 mg)<br>Oral placebo will be administered once-daily over 10 consecutive days | Drug: Placebo<br>* Participants will get 1 tablet (oral use) of placebo per day for 10 days<br>|
| Experimental: NNC0385-0434 100 mg<br>100 mg oral NNC0385-0434 will be administered once-daily over 10 consecutive days | Drug: NNC0385-0434<br>* Participants will get 1 tablet (oral use) of NNC0385-0434 per day for 10 days in either 15, 40 or 100 mg<br>|
| Placebo Comparator: Placebo (NNC0385-0434 100 mg)<br>Oral placebo will be administered once-daily over 10 consecutive days | Drug: Placebo<br>* Participants will get 1 tablet (oral use) of placebo per day for 10 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of treatment emergent adverse events (TEAEs) | Count of events | From pre-dose (day 1) until completion of the post-treatment period at follow-up (day 65) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-24h,0434,Day10,; the area under the NNC0385-0434 plasma concentration-time curve from time 0 to 24 h after last dose of oral NNC0385-0434 | h*nmol/L | From last dose (day 10) 0 to 24 hours post treatment (day 11) | 
| Cmax,0434,Day10,; the maximum plasma concentration of NNC0385-0434 after last dose of oral NNC0385-0434 | nmol/L | From last dose (day 10) 0 hours to post treatment follow-up (day 65) | 
| tmax,0434,Day10; the time to maximum observed plasma concentration of NNC0385-0434 after last dose of oral NNC0385-0434 | hours | From last dose (day 10) 0 hours to post treatment follow-up (day 65) | 
| t½,0434,Day10; the terminal half-life of NNC0385-0434 after last dose of oral NNC0385-0434 | hours | From last dose (day 10) 0 hours to post treatment follow-up (day 65) | 
| AUC0-24h,SNAC,Day10,; the area under the SNAC plasma concentration-time curve from time 0 to 24 h after last dose of oral NNC0385-0434 | h*nmol/L | From last dose (day 10) 0 to 24 hours post treatment (day 11) | 
| Cmax,SNAC,Day10; the maximum plasma concentration of SNAC after last dose of oral NNC0385-0434 | nmol/L | From last dose (day 10) 0 to 24 hours post treatment (day 11) | 
| tmax,SNAC,Day10; the time to maximum observed plasma concentration of SNAC after last dose of oral NNC0385-0434 | hours | From last dose (day 10) 0 to 24 hours post treatment follow-up (day 11) | 
| t½,SNAC,Day10; the terminal half-life of SNAC after last dose of oral NNC0385-0434 | hours | From last dose (day 10) 0 to 24 hours post treatment follow-up (day 11) |