Hepatic Impairment Clinical Trial
Official title:
A Multicenter, Non-randomized, Open-label, Parallel Controlled Phase I Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of SIM0417/Ritonavir After a Single Dose in Subjects With Renal or Hepatic Impairment
This is a multicenter, nonrandomized, open-label, parallel controlled Phase I clinical study to evaluate the Pharmacokinetics, Safety and Tolerability of SIM0417 combined with ritonavir after a single dose in subjects with mild and moderate renal impairment, moderate hepatic impairment, normal renal function, and normal hepatic function. It is divided into Part A (subjects with mild/moderate renal impairment and subjects with normal renal function) and Part B (subjects with moderate hepatic impairment and subjects with normal hepatic function).
This is a multicenter, non-randomized, open-label, parallel controlled Phase I clinical study to evaluate the Pharmacokinetics, Safety and Tolerability of SIM0417 combined with ritonavir after a single dose in subjects with mild and moderate renal impairment, moderate hepatic impairment, normal renal function, and normal hepatic function. Part A includes 4 cohorts, each of which plans to enroll 6-12 subjects, for a total of 24-48 subjects. Participants will be allocated into normal renal function or mild/moderate renal impairment groups based on their estimated glomerular filtration rate. Part B includes 2 cohorts, each of which plans to enroll 6-12 subjects, for a total of 12-24 subjects. Participants will be allocated into normal hepatic function or moderate hepatic impairment groups based on their Child-Pugh score. Each subject will receive SIM0417 combined with ritonavir administration. SIM0417 is single-dosed, and ritonavir is administered 12 hours before SIM0417 administration (-12 hours), at the time of SIM0417 administration (0 hour), 12 hours (12 hours) after SIM0417 administration, and 24 hours (24 hours) after SIM0417 administration. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT05009680 -
A Single and Repeat Dose Trial in Participants With Hepatic Impairment
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04494269 -
A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls
|
Phase 1 | |
| Terminated |
NCT05517226 -
Pharmacokinetics of Cotadutide in Participants With Hepatic Impairment
|
Phase 1 | |
| Completed |
NCT03983161 -
A Pharmacokinetics and Tolerability Study of Fedratinib in Subjects With Moderate and Severe Hepatic Impairment
|
Phase 1 | |
| Completed |
NCT04546789 -
Effect of Hepatic Impairment on M2951 (BTK Inhibitor) PK
|
Phase 1 | |
| Completed |
NCT03282513 -
A Study of AG-120 (Ivosidenib) in Subjects With Mild or Moderate Hepatic Impairment or Normal Hepatic Function
|
Phase 1 | |
| Recruiting |
NCT05976321 -
A Study of TAK-279 in Adults With or Without Liver Damage
|
Phase 1 | |
| Completed |
NCT04473664 -
A Study of Quizartinib Pharmacokinetics in Participants With Moderate Hepatic Impairment
|
Phase 1 | |
| Recruiting |
NCT05484206 -
Effect of Hepatic Impairment on the Pharmacokinetics and Safety of VIR-2218 and VIR-3434
|
Phase 1 | |
| Completed |
NCT03290443 -
A Study to Assess the Pharmacokinetics of Enasidenib (CC-90007) in Subjects With Moderate and Severe Hepatic Impairment.
|
Phase 1 | |
| Completed |
NCT02245243 -
Pharmacokinetics of Delafloxacin in Subjects With and Without Hepatic Impairment
|
Phase 1 | |
| Completed |
NCT02244827 -
Pharmacokinetics of WCK 2349 In Patients With Hepatic Impairment
|
Phase 1 | |
| Completed |
NCT02004587 -
Influence of Hepatic Impairment on Pharmacokinetic (PK) and Pharmacodynamic (PD) of Gemigliptin PK and PD After Multiple Oral Doses in Healthy White Volunteers
|
Phase 1 | |
| Completed |
NCT01621633 -
A Study of LCZ696 in Subjects With Mild and Moderate Hepatic Impairment Compared With Normal Healthy Volunteers
|
Phase 2 | |
| Completed |
NCT01493869 -
Study to Assess the Pharmacokinetics of Cabozantinib (XL184) in Hepatic Impaired Adult Subjects
|
Phase 1 | |
| Completed |
NCT04482270 -
A Study to Investigate the Effect of Mild and Moderate Hepatic Impairment on the Safety and Tolerability of Fezolinetant Compared to Participants With Normal Hepatic Function
|
Phase 1 | |
| Completed |
NCT02115347 -
Pharmacokinetics, Safety, and Tolerability of Ertugliflozin (MK-8835/PF-04971729) in Participants With Hepatic Impairment and in Healthy Participants (MK-8835-014)
|
Phase 1 | |
| Recruiting |
NCT04950764 -
An Open-Label Study Following Oral Dosing of Seladelpar to Subjects With Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI)
|
Phase 1 | |
| Completed |
NCT06161259 -
Pharmacokinetics of Leritrelvir(RAY1216) in Participants With Hepatic Impairment
|
Phase 1 | |
| Completed |
NCT05409911 -
A Study to Assess S-217622 in Participants With Mild and Moderate Hepatic Impairment and Healthy Control Participants
|
Phase 1 |