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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers; Atherosclerotic Cardiovascular Disease
• Intervention / Treatment: Drug: NNC0385-0434; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Fukuoka, Japan, 812-0025
    • Hakata Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 1452), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2021
• Primary Completion (Actual): January 19, 2022
• Study Completion (Actual): January 19, 2022

Study Registration Dates

• First Submitted: August 10, 2021
• First Submitted That Met QC Criteria: August 10, 2021
• First Posted (Actual): August 12, 2021

Study Record Updates

• Last Update Posted (Actual): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 16, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Cardiovascular Diseases; Atherosclerosis
• Other Study ID Numbers: NN6435-4748; U1111-1264-4546 (Other Identifier: World Health Organization (WHO)); jRCT2071210055 (Registry Identifier: JAPIC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: "According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No