Clinical Trials Logo

Clinical Trial Summary

The study will evaluate the influence of hepatic insufficiency on the PK of ACP-196.


Clinical Trial Description

This is a 2-part study. Part 1 of the study will compare the PK of ACP-196 in participants with mild hepatic insufficiency (a score of 5 to 6, on the Child-Pugh scale) and moderate hepatic insufficiency (a score of 7 to 9, on the Child-Pugh scale) to healthy (mean) matched control participants for age and weight. Part 2 of the study, if it is conducted, will compare the PK of ACP-196 in participants with severe hepatic insufficiency (a score of 10 to 15 on the Child-Pugh scale) to the healthy control participants from Part 1. In Part 1, 6 participants with mild hepatic insufficiency, 6 participants with moderate hepatic, and 6 healthy control participants matched to the hepatic insufficiency groups according to mean age and mean weight will be enrolled. In Part 2, if conducted, 6 participants with severe hepatic insufficiency will be enrolled. The control group of Part 1 will be used for Part 2 PK comparison. Participants will be screened within 28 days before the dose. Participants will be contacted approximately 14 days after the last dose of study drug administration to determine if any adverse event has occurred since the last dose of study drug. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04867941
Study type Interventional
Source Acerta Pharma BV
Contact
Status Completed
Phase Phase 1
Start date October 21, 2014
Completion date February 2, 2015

See also
  Status Clinical Trial Phase
Completed NCT04097704 - Pharmacogenetics Sampling of the CC-90007-CP-003 Study Cohort
Completed NCT02161224 - A Study to Investigate the Exposure and Safety and Tolerability of a Single Dose of FG-4592 in Subjects With Moderately Diminished Liver Function Compared to Those With Normal Liver Function Phase 1
Completed NCT00929032 - Liver Transplantation and Reticuloendothelial Clearance Capacity N/A
Completed NCT00509210 - Study of Telaprevir in Subjects With Hepatic Impairment Phase 1
Completed NCT02894385 - Effect of Hepatic and Renal Impairment on the Pharmacokinetics, Safety and Tolerability of BAY1841788 (ODM-201) Phase 1
Completed NCT03306667 - Clinical Pharmacology of FYU-981 (Subjects With Hepatic Insufficiency) Phase 1
Recruiting NCT02457702 - Mitochondrial Function in Patients With Severe Liver Disease N/A
Completed NCT02090621 - Extracorporeal Photopheresis After Liver Transplant Phase 2
Completed NCT02249442 - Study to Determine the Pharmacokinetics on TPV/r in Subjects With Mild and Moderate Hepatic Insufficiency Phase 1
Completed NCT03341884 - A Study of Ipatasertib in Participants With Mild, Moderate or Severe Hepatic Impairment Compared to Healthy Participants Phase 1
Completed NCT01475136 - A Study of LY2140023 in Hepatic Impaired Participants Phase 1
Completed NCT00969813 - A Safety and Tolerability Study of CP-690,550 in Subjects With Hepatic Impairment and Normal Hepatic Function Phase 1
Completed NCT00968591 - Pharmacokinetics of Everolimus in Subjects With Hepatic Insufficiency Phase 1
Completed NCT00931060 - Effects of Branched-Chain Amino Acids on Muscle Ammonia Metabolism in Patients With Cirrhosis and Healthy Subjects N/A
Completed NCT00416702 - Safety and Pharmacokinetics of Indacaterol in Healthy Subjects and Those With Impaired Liver Function Phase 1
Completed NCT03968848 - Investigate the Influence of Severe Hepatic Impairment on the Pharmacokinetics of Acalabrutinib and Its Metabolite Phase 1
Completed NCT00692341 - Evaluation Of Hepatic Impairment On AG-013736 Pharmacokinetics Phase 1
Completed NCT00314054 - Study Evaluating the Safety of HCV-796 in Subjects With Liver Disease and in Healthy Adults Phase 1
Completed NCT00144248 - A Pharmacokinetic Study to Assess Nevirapine [Viramune] Levels in HIV Infected Patients With Impaired Hepatic Functions Phase 4
Recruiting NCT03842761 - A Study to Test How Different Doses of BI 685509 Are Tolerated in Patients With Liver Problems Phase 1