- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07715149
A Pharmacokinetic Study of D-2570 in Participants With Hepatic Impairment and Normal Hepatic Function
This is a single-center, non-randomized, open-label, parallel-group study. It will test D-2570 in people with liver problems and in people with healthy livers, to see how the drug moves through the body and whether it is safe.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
This is a single-center, non-randomized, open-label, parallel-controlled study designed to evaluate the pharmacokinetic profile and safety of D-2570 in participants with hepatic impairment and those with normal hepatic function. Participants with hepatic impairment will be enrolled first, followed by participants with normal hepatic function.
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 1
Kontakter och platser
Studiekontakt
- Namn: Huan Zhou
- Telefonnummer: +86 0552-3085747
- E-post: zhouhuanbest@vip.163.com
Studieorter
-
-
Anhui
-
Bengbu, Anhui, Kina, 233004
- Rekrytering
- The First Affiliated Hospital of Bengbu Medical University
-
Kontakt:
- Huan Zhou
- Telefonnummer: +86 0552-3085747
- E-post: zhouhuanbest@vip.163.com
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Voluntarily participate in this study and sign the written informed consent form after full informed consent, and agree to comply with the procedures specified in the study protocol.
- Aged 18 to 70 years.
- Both males and females are eligible.
- Male participants must weigh no less than 50 kg, and female participants must weigh no less than 45 kg.
- Participants with normal hepatic function must have adequate hematologic, renal, and hepatic function.
- Have no plan to reproduce or donate sperm/eggs from screening until 30 days after the last dose of study drug, and agree to either completely abstain from sexual intercourse or use effective contraceptive measures from screening until 30 days after the last dose of study drug, as detailed in Appendix 3.
Exclusion Criteria:
- Have undergone any prior surgery that may affect drug absorption, distribution, metabolism, or excretion, which, in the opinion of the investigator, would make the participant unsuitable for enrollment.
- Are female and currently lactating, or have a positive serum pregnancy test result at screening or during the study period.
- Have a known history of drug or substance abuse, or test positive for drugs of abuse on the urine drug screen.
- Have participated in another interventional clinical trial within 3 months prior to screening, or are currently participating in another clinical trial (participants who withdraw from a prior trial before treatment, i.e., were not randomized or did not receive study intervention, may be enrolled in this study).
- Have received a live vaccine within 2 months prior to study drug administration, or intend to receive a live vaccine during the study period.
- Have any other condition or finding that, in the opinion of the investigator, would make the participant unsuitable for participation in this study.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: D-2570 Group 1
D-2570 Group 1 |
D-2570 tablet, administered orally as a single dose |
|
Experimentell: D-2570 Group 2
D-2570 Group 2 |
D-2570 tablet, administered orally as a single dose |
|
Experimentell: D-2570 Group 3
D-2570 Group 3 |
D-2570 tablet, administered orally as a single dose |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
The main PK parameters -Time to maximum measured plasma concentration -Tmax Population pharmacokinetic characteristics of D-2570
Tidsram: Up to 192 hours after the last dose
|
The main PK parameters -Time to maximum measured plasma concentration -Tmax |
Up to 192 hours after the last dose
|
|
Maximum observed plasma concentration-Cmax
Tidsram: Up to 192 hours after the last dose
|
Maximum observed plasma concentration-Cmax |
Up to 192 hours after the last dose
|
|
The main PK parameters Half-life -t1/2
Tidsram: Up to 192 hours after the last dose
|
The main PK parameters Half-life -t1/2 |
Up to 192 hours after the last dose
|
|
The main PK parameters#Area under the plasma concentration versus time curve-AUC
Tidsram: Up to 192 hours after the last dose
|
The main PK parameters#Area under the plasma concentration versus time curve-AUC |
Up to 192 hours after the last dose
|
|
The main PK parameters-CL/F (apparent clearance)
Tidsram: Up to 192 hours after the last dose
|
The main PK parameters-CL/F (apparent clearance) |
Up to 192 hours after the last dose
|
|
The main PK parameters-Vz/F (apparent volume of distribution)
Tidsram: Up to 192 hours after the last dose
|
The main PK parameters-Vz/F (apparent volume of distribution) |
Up to 192 hours after the last dose
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Incidence of adverse events
Tidsram: Up to Day9
|
Incidence of adverse events |
Up to Day9
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Huan Zhou, The First Affiliated Hospital of Bengbu Medical University
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- D2570-106
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