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

NCT05003440 | Completed Phase 1

• 3 other identifiers: NN6435-4748U1111-1264-4546jRCT2071210055
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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. 1.NNC0385-0434 (a potential new medicine) in one of three different doses: 15 mg, 40 mg, or 100 mg.
2. 2.placebo (a dummy medicine which looks like the study medicine but without any medicine).

Conditions

Healthy Volunteers; Atherosclerotic Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

  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

  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

  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

  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

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

Study Arms (6)

NNC0385-0434 15 mg

EXPERIMENTAL

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

Drug: NNC0385-0434

Placebo (NNC0385-0434 15 mg)

PLACEBO COMPARATOR

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

Drug: Placebo

NNC0385-0434 40 mg

EXPERIMENTAL

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

Drug: NNC0385-0434

Placebo (NNC0385-0434 40 mg)

PLACEBO COMPARATOR

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

Drug: Placebo

NNC0385-0434 100 mg

EXPERIMENTAL

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

Drug: NNC0385-0434

Placebo (NNC0385-0434 100 mg)

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

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

NNC0385-0434 100 mg; NNC0385-0434 15 mg; NNC0385-0434 40 mg

Placebo DRUG

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

Placebo (NNC0385-0434 100 mg); Placebo (NNC0385-0434 15 mg); Placebo (NNC0385-0434 40 mg)

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Hakata Clinic

Fukuoka, 812-0025, Japan

Location

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Clinical Transparency (dept. 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: August 10, 2021
• First Posted: August 12, 2021
• Study Start: August 19, 2021
• Primary Completion: January 19, 2022
• Study Completion: January 19, 2022
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share

Locations

JP (1)