A Bioavailability Study Comparing the Pharmacokinetics of CDR132L Following Subcutaneous and Intravenous Administration in Healthy Participants
A Bioavailability Study Comparing the Pharmacokinetics of CDR132L Following Subcutaneous and Intravenous Administration in Healthy Participants
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.
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).
clinicaltrials@novonordisk.com(+1) 866-867-7178