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Completed

NCT Number: NCT05003440

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

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.

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Key information

Conditions

Healthy Volunteers Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Atherosclerotic Cardiovascular Disease Cardiovascular Diseases Vascular Diseases

Age range

20 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Hakata Clinic

Fukuoka, 812-0025, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NNC0385-0434

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Number of treatment emergent adverse events (TEAEs)

    Time frame: From pre-dose (day 1) until completion of the post-treatment period at follow-up (day 65)

    Count of events

Secondary outcomes

  1. 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

    Time frame: From last dose (day 10) 0 to 24 hours post treatment (day 11)

    h*nmol/L

  2. Cmax,0434,Day10,; the maximum plasma concentration of NNC0385-0434 after last dose of oral NNC0385-0434

    Time frame: From last dose (day 10) 0 hours to post treatment follow-up (day 65)

    nmol/L

  3. tmax,0434,Day10; the time to maximum observed plasma concentration of NNC0385-0434 after last dose of oral NNC0385-0434

    Time frame: From last dose (day 10) 0 hours to post treatment follow-up (day 65)

    hours

  4. t½,0434,Day10; the terminal half-life of NNC0385-0434 after last dose of oral NNC0385-0434

    Time frame: From last dose (day 10) 0 hours to post treatment follow-up (day 65)

    hours

  5. 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

    Time frame: From last dose (day 10) 0 to 24 hours post treatment (day 11)

    h*nmol/L

  6. Cmax,SNAC,Day10; the maximum plasma concentration of SNAC after last dose of oral NNC0385-0434

    Time frame: From last dose (day 10) 0 to 24 hours post treatment (day 11)

    nmol/L

  7. tmax,SNAC,Day10; the time to maximum observed plasma concentration of SNAC after last dose of oral NNC0385-0434

    Time frame: From last dose (day 10) 0 to 24 hours post treatment follow-up (day 11)

    hours

  8. t½,SNAC,Day10; the terminal half-life of SNAC after last dose of oral NNC0385-0434

    Time frame: From last dose (day 10) 0 to 24 hours post treatment follow-up (day 11)

    hours

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 12, 2021
Registry last updated
Jan 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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