- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07656454
A Study Understanding How Much CDR132L Enters the Bloodstream After Injection Under the Skin Compared to Injection Into a Vein in Healthy Participants
25. juni 2026 opdateret af: Novo Nordisk A/S
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.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
32
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Novo Nordisk
- Telefonnummer: (+1) 866-867-7178
- E-mail: clinicaltrials@novonordisk.com
Studiesteder
-
-
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Berlin, Tyskland, 14050
- Rekruttering
- Parexel International GmbH
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ja
Beskrivelse
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).
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Sequence A
Participants will be given dose 1 of CDR132L intravenously, followed by dose 1 of CDR132L administered subcutaneously.
|
CDR132L will be administered subcutaneously.
CDR132L will be administered intravenously.
|
|
Eksperimentel: Sequence B
Participants will be given dose 1 of CDR132L subcutaneously, followed by dose 1 of CDR132L administered intravenously.
|
CDR132L will be administered subcutaneously.
CDR132L will be administered intravenously.
|
|
Eksperimentel: Sequence C
Participants will be given dose 2 of CDR132L intravenously, followed by dose 2 of CDR132L administered subcutaneously.
|
CDR132L will be administered subcutaneously.
CDR132L will be administered intravenously.
|
|
Eksperimentel: Sequence D
Participants will be given dose 2 of CDR132L subcutaneously, followed by dose 2 of CDR132L administered intravenously.
|
CDR132L will be administered subcutaneously.
CDR132L will be administered intravenously.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
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
Tidsramme: From 0 to 840 hours after CDR132L administration
|
Measured as hours*nanograms per milliliter (h*ng/mL)
|
From 0 to 840 hours after CDR132L administration
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Area under the CDR132L plasma concentration-time curve from 0 hours and extrapolated to infinity after a single dose
Tidsramme: From 0 to 840 hours after CDR132L administration
|
Measured as h*ng/mL
|
From 0 to 840 hours after CDR132L administration
|
|
Maximum observed CDR132L plasma concentration after a single dose
Tidsramme: From 0 to 840 hours after CDR132L administration
|
Measured as nanograms per milliliter (ng/mL)
|
From 0 to 840 hours after CDR132L administration
|
|
Maximum observed CDR132L plasma concentration after a single dose divided by dose
Tidsramme: From 0 to 840 hours after CDR132L administration
|
Measured as nanograms per milliliter per milligram (ng/mL/mg)
|
From 0 to 840 hours after CDR132L administration
|
|
Time to maximum observed CDR132L plasma concentration after a single dose
Tidsramme: From 0 to 840 hours after CDR132L administration
|
Measured in hours
|
From 0 to 840 hours after CDR132L administration
|
|
Terminal half-life for CDR132L after a single dose
Tidsramme: From 0 to 840 hours after CDR132L administration
|
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
Tidsramme: From 0 to 840 hours after CDR132L administration
|
Measured as hours*nanograms per milliliter per milligram (h*ng/mL/mg)
|
From 0 to 840 hours after CDR132L administration
|
|
Total plasma clearance of CDR132L after a single dose
Tidsramme: From 0 to 840 hours after CDR132L administration
|
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
Tidsramme: From 0 to 840 hours after CDR132L administration
|
Measured in liters
|
From 0 to 840 hours after CDR132L administration
|
|
Mean residence time for CDR132L after a single dose
Tidsramme: From 0 to 840 hours after CDR132L administration
|
Measured in hours
|
From 0 to 840 hours after CDR132L administration
|
|
Number of adverse events
Tidsramme: From first CDR132L administration (day 1) to day 141
|
Measured as number of events
|
From first CDR132L administration (day 1) to day 141
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Clinical Transparency (dept. 2834), Novo Nordisk A/S
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
17. juni 2026
Primær færdiggørelse (Anslået)
31. december 2026
Studieafslutning (Anslået)
31. december 2026
Datoer for studieregistrering
Først indsendt
14. juni 2026
Først indsendt, der opfyldte QC-kriterier
14. juni 2026
Først opslået (Faktiske)
18. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
30. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NN6706-8230
- U1111-1319-6249 (Anden identifikator: World Health Organization (WHO))
- 2025-521329-34 (Anden identifikator: European Medical Agency (EMA))
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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