Healthy Volunteers, Heart Failure
Conditions
Brief summary
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.
Interventions
DRUGCDR132L (i.v.)
CDR132L will be administered intravenously.
DRUGCDR132L (s.c.)
CDR132L will be administered subcutaneously.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female (sex at birth). * Age 18-55 years (both inclusive) at the time of signing the informed consent. * Body mass index 18.5-29.9 kilograms per square metre (kg/m\^2) (both inclusive) and body weight less than or equal to (≤) 120 kilograms (kg) at screening (visit 1). * Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit (visit 1), as judged by the investigator.
Exclusion criteria
* Any laboratory safety parameters at screening (visit 1) outside the below laboratory ranges, see laboratory manual for specific values. * Alanine aminotransferase (ALT) greater than (\>) upper limit of normal (ULN) +10 percentage (%) * Aspartate aminotransferase (AST) \>ULN +20% * Bilirubin \>ULN +20% * Creatinine \>ULN +10% * Estimated glomerular filtration rate (eGFR) (Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\]) less than (\<) 90 milliliters per minute/1.73square meter (mL/min/1.73m\^2) * Urine albumin-to-creatinine ratio (UACR) greater than or equal to (≥) 30 milligrams per gram (mg/g) * 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | From 0 to 840 hours after CDR132L administration | Measured as hours\*nanograms per milliliter (h\*ng/mL) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under the CDR132L plasma concentration-time curve from 0 hours and extrapolated to infinity after a single dose | From 0 to 840 hours after CDR132L administration | Measured as h\*ng/mL |
| Maximum observed CDR132L plasma concentration after a single dose | From 0 to 840 hours after CDR132L administration | Measured as nanograms per milliliter (ng/mL) |
| Time to maximum observed CDR132L plasma concentration after a single dose | From 0 to 840 hours after CDR132L administration | Measured in hours |
| Terminal half-life for CDR132L after a single dose | From 0 to 840 hours after CDR132L administration | Measured in hours |
| 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 | From 0 to 840 hours after CDR132L administration | Measured as hours\*nanograms per milliliter per milligram (h\*ng/mL/mg) |
| Maximum observed CDR132L plasma concentration after a single dose divided by dose | From 0 to 840 hours after CDR132L administration | Measured as nanograms per milliliter per milligram (ng/mL/mg) |
| Total plasma clearance of CDR132L after a single dose | From 0 to 840 hours after CDR132L administration | Measured as liters per hour |
| Apparent volume of distribution of CDR132L after a single dose based on plasma concentration values | From 0 to 840 hours after CDR132L administration | Measured in liters |
| Mean residence time for CDR132L after a single dose | From 0 to 840 hours after CDR132L administration | Measured in hours |
| Number of adverse events | From first CDR132L administration (day 1) to day 141 | Measured as number of events |
Countries
Germany
Contacts
CONTACTNovo Nordisk
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed