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The Study is to Investigate D-2570 in Participants With Different Levels of Kidney Function. (D2570-107)

21. juli 2026 oppdatert av: InventisBio Co., Ltd

A Study to Evaluate the Pharmacokinetics of D-2570 in Participants With Renal Impairment Compared to Those With Normal Renal Function

This study is divided two parts into: Part A and Part B. Part A will recruit 24 research participants, and Part B will recruit 16 research participants.

Studieoversikt

Status

Har ikke rekruttert ennå

Intervensjon / Behandling

Detaljert beskrivelse

Subjects of this study will be admitted to the Phase I ward of the research center one day before drug administration . On the first day, subjects will orally take a single dose of D-2570. The researchers will collect a series of blood and urine samples before and after drug D - 2570 administration to determine the drug concentration and evaluate the pharmacokinetic characteristics. The subjects can leave site after completing the safety evaluation.

Studietype

Intervensjonell

Registrering (Antatt)

40

Fase

  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

    • Anhui
      • Hefei, Anhui, Kina, 230022
        • The First Affiliated Hospital of Anhui Medical University
        • Ta kontakt med:

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

Ja

Beskrivelse

Inclusion Criteria:

  • Voluntarily participate in this study after adequate informed consent, sign the written informed consent form, and agree to comply with all procedures specified in the study protocol;
  • Aged 18 to 70 years (inclusive). Age matching will be conducted between the normal renal function group and the matched renal impairment group with a mean difference within ±10 years;
  • Male and female participants are eligible. Gender matching will be performed between the normal renal function group and the matched renal impairment group with a difference of no more than 1 subject;
  • Male participants weigh no less than 50 kg, and female participants weigh no less than 45 kg. Body mass index (BMI) = weight (kg) / height squared (m²), ranging from 19 to 30 kg/m² (inclusive). Weight matching will be conducted between the normal renal function group and the matched renal impairment group with a mean difference within ±10 kg;

Exclusion Criteria:

  • Allergic constitution (e.g., allergy to pollen, two or more types of drugs/foods), or history of atopic diseases such as asthma and urticaria, or known hypersensitivity to the study drug or its excipients;
  • Positive T-SPOT result at screening. Combined with clinical signs and chest posteroanterior X-ray findings, the participant is judged by the investigator to have active pulmonary tuberculosis;

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: participants with normal renal function
Subjects will receive a single dose of D-2570
receive a single dose of D-2570
Eksperimentell: participants with Mild Renal Impairment
Subjects will receive a single dose of D-2570 (Part B)
receive a single dose of D-2570
Eksperimentell: participants with Moderate Renal Impairment
Subjects will receive a single dose of D-2570 (Part A)
receive a single dose of D-2570
Eksperimentell: participants with Severe Renal Impairment
Subjects will receive a single dose of D-2570 (Part A)
receive a single dose of D-2570

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
The main PK parameters -Time to maximum measured plasma concentration -Tmax
Tidsramme: Through study completion (approximately Day9)
The main PK parameters -Time to maximum measured plasma concentration -Tmax
Through study completion (approximately Day9)
Maximum observed plasma concentration-Cmax
Tidsramme: Through study completion (approximately Day9)
Maximum observed plasma concentration-Cmax
Through study completion (approximately Day9)
The main PK parameters Half-life -t1/2
Tidsramme: Through study completion (approximately Day9)
The main PK parameters Half-life -t1/2
Through study completion (approximately Day9)
The main PK parameters#Area under the plasma concentration versus time curve-AUC
Tidsramme: Through study completion (approximately Day9)
The main PK parameters#Area under the plasma concentration versus time curve-AUC
Through study completion (approximately Day9)
The main PK parameters-CL/F (apparent clearance)
Tidsramme: Through study completion (approximately Day9)
The main PK parameters-CL/F (apparent clearance)
Through study completion (approximately Day9)
The main PK parameters-Vz/F (apparent volume of distribution)
Tidsramme: Through study completion (approximately Day9)
The main PK parameters-Vz/F (apparent volume of distribution)
Through study completion (approximately Day9)
The cumulative excretion amount (Aeu)
Tidsramme: Through study completion (approximately Day9)
The cumulative excretion (Aeu) of D - 2570 and its metabolites in urine
Through study completion (approximately Day9)
The fraction of drug excreted in urine (Feu)
Tidsramme: Through study completion (approximately Day9)
The fraction of drug excreted in urine (Feu) of D - 2570 and its metabolites in urine
Through study completion (approximately Day9)
The renal clearance rate (CLR)
Tidsramme: Through study completion (approximately Day9)
The renal clearance rate (CLR)of D - 2570 and its metabolites in urine
Through study completion (approximately Day9)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of participants with treatment-related adverse events as assessed by CTCAE v6.0
Tidsramme: Through study completion (approximately Day9)
Incidence of adverse events
Through study completion (approximately Day9)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Huan Zhou, Doctor, The First Affiliated Hospital of Anhui Medical University

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)

9. august 2026

Primær fullføring (Antatt)

21. november 2026

Studiet fullført (Antatt)

21. november 2026

Datoer for studieregistrering

Først innsendt

13. juli 2026

Først innsendt som oppfylte QC-kriteriene

15. juli 2026

Først lagt ut (Faktiske)

20. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

23. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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