- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07715175
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
- Navn: Huan Zhou, Doctor
- Telefonnummer: 13665527160
- E-mail: zhouhuanbest@vip.163.com
Undersøgelse Kontakt Backup
- Navn: Dingli Yao, Bachelor's
- Telefonnummer: 15538261075
- E-mail: dingli.yao@inventisbio.com
Studiesteder
-
-
Anhui
-
Hefei, Anhui, Kina, 230022
- The First Affiliated Hospital of Anhui Medical University
-
Kontakt:
- Huan Zhou, Doctor
- Telefonnummer: 13665527160
- E-mail: zhouhuanbest@vip.163.com
-
-
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.
Sponsor
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
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- D2570-107
- CTR20261754 (Anden identifikator: Clinicaltrials.gov)
Plan for individuelle deltagerdata (IPD)
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