Clinical Trials Logo
  1. Home
  2. Hepatic Impairment
  3. NCT04552808

To Evaluate the Pharmacokinetics and Safety of Yimitasvir Phosphate Capsules in Subjects With Moderate and Severe Liver Function Impairment and in Healthy Subjects

Hepatic Impairment Clinical Trial

Official title:
To Evaluate the Pharmacokinetics and Safety of Yimitasvir Phosphate Capsules in Subjects With Moderate and Severe Liver Function Impairment and Healthy Subjects in a Single-center, Non-randomized, Open, Single-dose Administration

Clinical Trial Summary

To evaluate the pharmacokinetics and safety of Yimitasvir phosphate capsules in subjects with moderate and severe liver function impairment and healthy subjects in a single-center, non-randomized, open, single-dose administration

Clinical Trial Description

A phase I, a single-center, non-randomized, open, single-dose administration study to explore the safety, pharmacokinetics of Yimitasvir phosphate capsules in subjects with moderate and severe liver function impairment and healthy subjects This study is divided into four cohorts, cohort A and cohort C in healthy subjects, cohort B for moderate liver function impairment participants, cohort D for severe liver function impairment, participants in cohort A and cohort B, group C and group D should be matched in terms of sex, age, and body mass index (BMI). A total of 32 subjects, 8 in each cohort, both male and female, are planned to be enrolled. If a complete PK blood sample is not collected due to subjects' early withdrawal from the study, new subjects will be enrolled to meet the pharmacokinetic parameters that can be evaluated for each cohort of 8 subjects. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04552808
Study type Interventional
Source Sunshine Lake Pharma Co., Ltd.
Contact
Status Completed
Phase Phase 1
Start date October 19, 2020
Completion date June 9, 2022
View Details
See also
  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