Clinical Trials Logo
  1. Home
  2. Hepatic Impairment
  3. NCT04190654

Single-dose Study to Investigate the Plasma PK of KW-6356 and Its Major Metabolite

Hepatic Impairment Clinical Trial

Official title:
A Pharmacokinetic Study of KW-6356 in Subjects With Mild and Moderate Hepatic Impairment Compared to Subjects With Normal Hepatic Function

Clinical Trial Summary

This is an open-label, non-randomized, single-dose study to investigate the plasma PK of KW-6356 and its major metabolite, after a single oral dose of KW-6356, in subjects with mild or moderate hepatic impairment and in healthy adults

Clinical Trial Description

Potential subjects will be screened to assess their eligibility to enter the study within 4 weeks prior to dose administration. Eligible subjects will be admitted to the clinical research unit (CRU) before the initiation of investigational medicinal product (IMP) administration (Check-in/Day -1) and administered of KW-6356 orally on Day 1 after an 8-hour fast. Those subjects who complete all the scheduled observations/examinations and are determined to have no clinical abnormalities requiring further hospitalization by the Investigator, will be discharged from the study site on Day 4. Discharged subjects will then visit the CRU on the scheduled visit Days 5, 6, 7, 8 for PK sample collections and safety assessments on Day 12 to complete the End of Study (EOS) visit. The duration of hospitalization will be 5 days: 4 nights from Day -1 to Day 4. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04190654
Study type Interventional
Source Kyowa Kirin Co., Ltd.
Contact
Status Completed
Phase Phase 1
Start date November 26, 2019
Completion date March 20, 2020
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 NCT05481411 - A Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Olpasiran in Participants With Various Degrees of Hepatic Impairment Phase 1