- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07715175
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
Forhold
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
- Navn: Huan Zhou, Doctor
- Telefonnummer: 13665527160
- E-post: zhouhuanbest@vip.163.com
Studer Kontakt Backup
- Navn: Dingli Yao, Bachelor's
- Telefonnummer: 15538261075
- E-post: dingli.yao@inventisbio.com
Studiesteder
-
-
Anhui
-
Hefei, Anhui, Kina, 230022
- The First Affiliated Hospital of Anhui Medical University
-
Ta kontakt med:
- Huan Zhou, Doctor
- Telefonnummer: 13665527160
- E-post: zhouhuanbest@vip.163.com
-
-
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.
Sponsor
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
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- D2570-107
- CTR20261754 (Annen identifikator: Clinicaltrials.gov)
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
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