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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1264-4546 | Other Identifier | World Health Organization (WHO) | |
| jRCT2071210055 | Registry Identifier | JAPIC |
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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
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NNC0385-0434 15 mg | Experimental | 15 mg oral NNC0385-0434 will be administered once-daily over 10 consecutive days |
|
| Placebo (NNC0385-0434 15 mg) | Placebo Comparator | Oral placebo will be administered once-daily over 10 consecutive days |
|
| NNC0385-0434 40 mg | Experimental | 40 mg oral NNC0385-0434 will be administered once-daily over 10 consecutive days |
|
| Placebo (NNC0385-0434 40 mg) | Placebo Comparator | Oral placebo will be administered once-daily over 10 consecutive days |
|
| NNC0385-0434 100 mg | Experimental | 100 mg oral NNC0385-0434 will be administered once-daily over 10 consecutive days |
|
| Placebo (NNC0385-0434 100 mg) | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hakata Clinic | Fukuoka | 812-0025 | Japan |
"According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"
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| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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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).
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Oral placebo will be administered once-daily over 10 consecutive days
|
| Placebo | Drug | Participants will get 1 tablet (oral use) of placebo per day for 10 days |
|
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) |