- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07808788
A Research Study Looking Into How a Single Dose of the Medicine NNC0537-1482 Moves Through the Body of Participants With Normal or Reduced Kidney Function
2. september 2026 oppdatert av: Novo Nordisk A/S
Investigation of Pharmacokinetics of a Single Subcutaneous Dose of NNC0537-1482 in Participants With Various Degrees of Renal Function
The purpose of the study to find out how the study medicine NNC0537-1482 moves through the body in people living with reduced kidney function compared to people with normal kidney function.
All participants will get a single dose of the new medicine.
The data for how much medicine is in the blood over time and compare levels between people with reduced and normal kidney function.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
54
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Novo Nordisk
- Telefonnummer: (+1) 866-867-7178
- E-post: clinicaltrials@novonordisk.com
Studiesteder
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Berlin, Tyskland, 10117
- Charité - Campus Charité Mitte - Charité Research Organisation GmbH
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Body Mass Index (BMI) between 18.5 and 39.9 Kilogram per meter square (kg/m^2) (both inclusive) at screening.
- Meeting the pre-defined estimated glomerular filtration rate (eGFR) values based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation (2021) adjusted for the estimated individual body surface area for any of the below renal function groups at screening (Note: The participant must be/have been in their usual health condition at the time of sample collection used for inclusion, as evaluated by the investigator. This will indicate that the participant does not have an acute kidney dysfunction):
Normal renal function: greater than or equal to (≥) 90, Mild renal impairment: 60-89, Moderate renal impairment: 30-59, Severe renal impairment: 15-29 not requiring dialysis, ESRD: less than (<)15 and requiring dialysis treatment.
- All participants in the renal impairment groups should have had chronic kidney disease for at least 3 months prior to screening.
- For participants with ESRD requiring dialysis treatment:
Current treatment with haemodialysis for at least 3 months prior to screening.
Exclusion Criteria:
- Any condition which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- Presence or history of any clinically relevant respiratory, metabolic, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions (except conditions associated with renal impairment or ESRD).
- Use of medicinal products known to affect creatinine clearance including cephalosporin and aminoglycoside antibiotics, flucytosine, cisplatin, cimetidine, trimethoprim, cibenzoline, and nitrofurantoin within 14 days or 5 half-lives, whichever is greater, before planned dosing with the investigational medicinal product (IMP).
- Ongoing treatment with nitrates or nitric oxide (NO) donors (for any route; including isosorbide dinitrate, isosorbide 5 mononitrate, pentaerythritol tetranitrate, nicorandil, nitroglycerin , molsidomine), neprilysin inhibitors (including angiotensin receptor/neprilysin inhibitors), phosphodiesterase (PDE) inhibitors (including PDE3, PDE4, PDE5 inhibitors), or soluble guanylate cyclase (sGC) stimulators.
- Note for participants on dialysis: short-term use of nitroglycerin spray for acute hypertensive episodes or emergencies may be permitted at the investigator's discretion if nitroglycerin is administered as single, short acting dose to treat an acute event (i.e., not scheduled, not for chronic/continuous use); dose, time of administration and reason should be documented in the source documents.
- Specific exclusion criterion for participants with normal renal function:
- Blood pressure at screening outside the range of 100-145 millimetres of mercury (mmHg) for systolic or outside the range of 50-99 mmHg for diastolic.
- Specific exclusion criterion for participants with renal impairment or ESRD:
- Blood pressure at screening outside the range of 100-160 mmHg for systolic and/or ≥100 mmHg for diastolic.
- Unstable renal function within the last 3 months before screening as judged by the investigator, or acute exacerbation of renal disease within 14 days before screening.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: NNC0537-1482
Participants will be administered NNC0537-1482 single dose subcutaneously.
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NNC0537-1482 vil bli administrert subkutant.
A placebo was used for dilution of the investigational medicinal product.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Area under the NNC0537-1482 plasma concentration-time curve from 0 hours to the time of the last quantifiable concentration (AUC0-tz) in participant with normal function and mild, moderate and severe impairment
Tidsramme: From pre-dose (Day 1) until Day 36
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Measured as hour per nanomoles per liter (h*nmol/L).
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From pre-dose (Day 1) until Day 36
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Maximum observed NNC0537-1482 plasma concentration (Cmax) in participant with normal function and mild, moderate and severe impairment
Tidsramme: From pre-dose (Day 1) until Day 36
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Measured as nanomoles per liter (nmol/L).
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From pre-dose (Day 1) until Day 36
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Time to maximum observed NNC0537-1482 plasma concentration (tmax) in participant with normal function and mild, moderate and severe impairment
Tidsramme: From pre-dose (Day 1) until Day 36
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Measured as hours.
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From pre-dose (Day 1) until Day 36
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Area under the NNC0537-1482 plasma concentration-time curve from 0 hours to the time of the last quantifiable concentration (AUC0-tz) in participant with end-stage renal disease (ESRD)
Tidsramme: From pre-dose (Day 1) until Day 36
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Measured as h*nmol/L.
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From pre-dose (Day 1) until Day 36
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Maximum observed NNC0537-1482 plasma concentration (Cmax) in participant with end-stage renal disease (ESRD)
Tidsramme: From pre-dose (Day 1) until Day 36
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Measured as nmol/L.
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From pre-dose (Day 1) until Day 36
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Time to maximum observed NNC0537-1482 plasma concentration (tmax) in participant with end-stage renal disease (ESRD)
Tidsramme: From pre-dose (Day 1) until Day 36
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Measured as hours.
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From pre-dose (Day 1) until Day 36
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Number of treatment emergent adverse events (TEAEs)
Tidsramme: From time of trial product administration (Day 1) until Day 36
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Measured as Events.
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From time of trial product administration (Day 1) until Day 36
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Clinical Transparency dept. 2834, Organizational Affiliation Enter 'Novo Nordisk A/S
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
4. september 2026
Primær fullføring (Antatt)
6. juli 2027
Studiet fullført (Antatt)
6. juli 2027
Datoer for studieregistrering
Først innsendt
2. september 2026
Først innsendt som oppfylte QC-kriteriene
2. september 2026
Først lagt ut (Faktiske)
9. september 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
9. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Urogenitale sykdommer
- Patologiske prosesser
- Mannlige urogenitale sykdommer
- Nyresykdommer
- Urologiske sykdommer
- Kvinnelige urogenitale sykdommer
- Kvinnelige urogenitale sykdommer og graviditetskomplikasjoner
- Kronisk sykdom
- Sykdomsattributter
- Nyreinsuffisiens
- Patologiske tilstander, tegn og symptomer
- Nyresvikt, kronisk
Andre studie-ID-numre
- NN6537-8759
- U1111-1335-3619 (Annen identifikator: World Health Organization (WHO))
- 2026-525271-57 (Annen identifikator: EU CT number)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
According to the Novo Nordisk disclosure commitment on novonordisktrials.com
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Ja
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