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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1264-2693 | Other Identifier | World Health Organization (WHO) | |
| 2021-000462-16 | EudraCT Number |
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Novo Nordisk is developing a new medicine, NNC0385-0434, to help people lower their cholesterol level.
The aim of this study is to look at how NNC0385-0434 works in the body and how it is removed from the body in people with impaired kidney function.
All participants will receive the same dose (100 mg) of the study medicine NNC0385-0434, which will be given for 10 days in a row. Participants will get the study medicine in a tablet taken orally once-daily. The study medicine needs to be taken in the morning after overnight fasting and 30 minutes before the first meal of the day.
The study will last for about 9-14 weeks.
Participants will have 15 visits to the study centre, including 2 in-house stays of 3 days and 2 nights and 13 ambulatory visits.
Participants' vital signs (heart rate, blood pressure, body temperature) will be measured, participants will have blood draws, urine will be collected and electrocardiograms (ECGs) will be recorded.
Participants cannot take part in the study if they have gastrointestinal disorders or unusual meal habits and special dietary requirements.
Women can only take part in the study if they cannot get pregnant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal renal function | Active Comparator | All participants will receive 100 mg of NNC0385-0434 in an oral tablet per day for 10 days |
|
| Mildly decreased renal function | Experimental | All participants will receive 100 mg of NNC0385-0434 in an oral tablet per day for 10 days |
|
| Moderately decreased renal function | Experimental | All participants will receive 100 mg of NNC0385-0434 in an oral tablet per day for 10 days |
|
| Severely decreased renal function | Experimental | All participants will receive 100 mg of NNC0385-0434 in an oral tablet per day for 10 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0385-0434 A 100 mg | Drug | All participants will receive the same dose (100 mg) of the study medicine NNC0385-0434, which will be given for 10 days in a row. Participants will get the study medicine in a tablet taken orally once-daily. The study medicine needs to be taken in the morning after overnight fasting and 30 minutes before the first meal of the day. |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-24h,0434,Day10: the area under the NNC0385-0434 plasma concentration-time curve from time 0 to 24 hours after last dose of oral NNC0385-0434 | Measured in h*nmol/L | From last dose (Day 10) to 24 hours post treatment (Day 11) |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax,0434,Day10: the maximum plasma concentration of NNC0385-0434 after last dose of oral NNC0385-0434 | nmol/L | From last dose (Day 10) to post treatment follow-up (Day 65) |
| tmax,0434,Day10: time from last dose administration to maximum plasma concentration of oral NNC0385-0434 |
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Inclusion Criteria:
Group description eGFR (mL/min)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Berlin | 10117 | Germany |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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|
h |
| From last dose (Day 10) to post treatment follow-up (Day 65) |
| t½,0434,Day10; the terminal half-life of NNC0385-0434 after last dose of oral NNC0385-0434 | h | From last dose (Day 10) to post treatment follow-up (Day 65) |
| CLR,0434,Day10; the renal clearance of NNC0385-0434 after last dose of oral NNC0385-0434 | mL/h | From last dose (Day 10) to 48 hours post treatment (Day 12) |
| AUC0-24h,SNAC,Day10: the area under the SNAC plasma concentration-time curve from time 0 to 24 hours after last dose of oral NNC0385-0434 | h*ng/mL | From last dose (Day 10) to 24 hours post treatment (Day 11) |
| Cmax,SNAC,Day10; the maximum plasma concentration of SNAC after last dose of oral NNC0385-0434 | ng/mL | From last dose (Day 10) to 24 hours post treatment (Day 11) |
| Cmin,SNAC,Day10; the minimum plasma concentration of SNAC before last dose of oral NNC0385-0434 | nmol/L | Pre-dose (Day 10) |
| 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) to 24 hours post treatment (Day 11) |
| CLR,SNAC,Day10; the renal clearance of SNAC after last dose of oral NNC0385-0434 | mL/h | From last dose (Day 10) to 48 hours post treatment (Day 12) |
| Number of treatment emergent adverse events (TEAEs) | Number of events | From first dose (Day 1) until completion of the post-treatment period at follow-up (Day 65) |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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