A Study Understanding How Much CDR132L Enters the Bloodstream After Injection Under the Skin Compared to Injection Into a Vein in Healthy Participants

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorNovo Nordisk A/S

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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/m²) (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.

Disqualifiers

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%

Trial design

Design model

Crossover

Treatments tested in this trial

  • CDR132L (i.v.)

    Drug

    CDR132L will be administered intravenously.

  • CDR132L (s.c.)

    Drug

    CDR132L will be administered subcutaneously.

Treatment groups

32 Participants
are divided into 4 treatment groups
Group A: Sequence AExperimental treatment 2 interventions
Group B: Sequence BExperimental treatment 2 interventions
Group C: Sequence CExperimental treatment 2 interventions
Group D: Sequence DExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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)

Time frame
From 0 to 840 hours after CDR132L administration

Secondary outcomes

1

Area under the CDR132L plasma concentration-time curve from 0 hours and extrapolated to infinity after a single dose

Measured as h\*ng/mL

Time frame
From 0 to 840 hours after CDR132L administration
2

Maximum observed CDR132L plasma concentration after a single dose

Measured as nanograms per milliliter (ng/mL)

Time frame
From 0 to 840 hours after CDR132L administration
3

Time to maximum observed CDR132L plasma concentration after a single dose

Measured in hours

Time frame
From 0 to 840 hours after CDR132L administration
4

Terminal half-life for CDR132L after a single dose

Measured in hours

Time frame
From 0 to 840 hours after CDR132L administration

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.