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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05003440
• Other study ID #: NN6435-4748
• Secondary ID: U1111-1264-4546j
• Status: Completed
• Phase: Phase 1
• Start date: August 19, 2021
• Est. completion date: January 19, 2022

Study information

• Verified date: January 2024
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 19, 2022
• Est. primary completion date: January 19, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Atherosclerotic Cardiovascular Disease
• Cardiovascular Diseases
• Healthy Volunteers

Intervention

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

Locations

Country	Name	City	State
Japan	Hakata Clinic	Fukuoka

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)