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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1319-6249 | Other Identifier | World Health Organization (WHO) | |
| 2025-521329-34 | Other Identifier | European Medical Agency (EMA) |
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This study is being done to understand how much of the medicine (CDR132L) enters the bloodstream after injection under the skin compared to injection into a vein in healthy people. This will help us find the best way to give the medicine to people living with heart failure. The study will assess what the body does to the medicine, and how safe it is.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence A | Experimental | Participants will be given dose 1 of CDR132L intravenously, followed by dose 1 of CDR132L administered subcutaneously. |
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| Sequence B | Experimental | Participants will be given dose 1 of CDR132L subcutaneously, followed by dose 1 of CDR132L administered intravenously. |
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| Sequence C | Experimental | Participants will be given dose 2 of CDR132L intravenously, followed by dose 2 of CDR132L administered subcutaneously. |
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| Sequence D | Experimental | Participants will be given dose 2 of CDR132L subcutaneously, followed by dose 2 of CDR132L administered intravenously. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CDR132L (i.v.) | Drug | CDR132L will be administered intravenously. |
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| Measure | Description | Time Frame |
|---|---|---|
| Area under the CDR132L plasma concentration-time curve (AUC 0-tz) from 0 hours to tz after a single dose, where tz is the time of last quantifiable concentration | Measured as hours*nanograms per milliliter (h*ng/mL) | From 0 to 840 hours after CDR132L administration |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the CDR132L plasma concentration-time curve from 0 hours and extrapolated to infinity after a single dose | Measured as h*ng/mL | From 0 to 840 hours after CDR132L administration |
| Maximum observed CDR132L plasma concentration after a single dose |
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Inclusion Criteria:
Exclusion Criteria:
Any laboratory safety parameters at screening (visit 1) outside the below laboratory ranges, see laboratory manual for specific values.
Second or third degree atrioventricular-block, prolongation of the QRS complex over 120 milliseconds (ms), or of the QT interval corrected using Fridericia's formula (QTcF) interval over 450 ms, or any other clinically significant abnormal electrocardiogram results as judged by the investigator at screening (visit 1).
Supine blood pressure at screening (visit 1) outside the range of 90-139 millimeters of mercury (mmHg) for systolic or 50-89 mmHg for diastolic.
Heart rate outside the range of 50-89 beats/minute at screening (visit 1).
Presence or history (as declared by the participant or reported in the medical records) of cardiovascular disease including stable and unstable angina pectoris, myocardial infarction, transient ischaemia, stroke, heart failure, cardiac decompensation, clinically significant arrhythmia and clinically significant conduction disorders.
Known history of severe symptomatic untreated anaemia in the 90 days prior to screening (visit 1) (e.g., haemoglobin <90 grams per litre (g/L))
Presence or history (as declared by the participant or reported in the medical records) of acute or chronic kidney disease or injury.
Presence of thrombocytopenia, defined as thrombocyte count <150 x 10^9 cells/L at screening (visit 1), or history (as declared by the participant or reported in the medical records) of bleeding disorder.
Presence or history (as declared by the participant or reported in the medical records) of conditions associated with disruption of blood-brain barrier (e.g. multiple sclerosis).
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novo Nordisk | Contact | (+1) 866-867-7178 | clinicaltrials@novonordisk.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parexel International GmbH | Recruiting | Berlin | 14050 | Germany |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| CDR132L (s.c.) | Drug | CDR132L will be administered subcutaneously. |
|
Measured as nanograms per milliliter (ng/mL) |
| From 0 to 840 hours after CDR132L administration |
| Time to maximum observed CDR132L plasma concentration after a single dose | Measured in hours | From 0 to 840 hours after CDR132L administration |
| Terminal half-life for CDR132L after a single dose | Measured in hours | From 0 to 840 hours after CDR132L administration |
| Area under the CDR132L plasma concentration-time curve from 0 hours to tz after a single dose, where tz is the time of last quantifiable concentration, divided by dose | Measured as hours*nanograms per milliliter per milligram (h*ng/mL/mg) | From 0 to 840 hours after CDR132L administration |
| Maximum observed CDR132L plasma concentration after a single dose divided by dose | Measured as nanograms per milliliter per milligram (ng/mL/mg) | From 0 to 840 hours after CDR132L administration |
| Total plasma clearance of CDR132L after a single dose | Measured as liters per hour | From 0 to 840 hours after CDR132L administration |
| Apparent volume of distribution of CDR132L after a single dose based on plasma concentration values | Measured in liters | From 0 to 840 hours after CDR132L administration |
| Mean residence time for CDR132L after a single dose | Measured in hours | From 0 to 840 hours after CDR132L administration |
| Number of adverse events | Measured as number of events | From first CDR132L administration (day 1) to day 141 |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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