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

21. juli 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

40

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

    • Anhui
      • Hefei, Anhui, Kina, 230022
        • The First Affiliated Hospital of Anhui Medical University
        • Kontakt:

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
  • Ældre voksen

Tager imod sunde 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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

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

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 (Anslået)

9. august 2026

Primær færdiggørelse (Anslået)

21. november 2026

Studieafslutning (Anslået)

21. november 2026

Datoer for studieregistrering

Først indsendt

13. juli 2026

Først indsendt, der opfyldte QC-kriterier

15. juli 2026

Først opslået (Faktiske)

20. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • D2570-107
  • CTR20261754 (Anden identifikator: Clinicaltrials.gov)

Plan for individuelle deltagerdata (IPD)

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