Hepatic Impairment Clinical Trial
Official title:
A Phase 1, Open-label, Multiple-dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Pacritinib in Subjects With Varying Degrees of Hepatic Impairment Compared to Healthy Subjects
This is a Phase 1 study designed to assess the effect of hepatic insufficiency on the PK of pacritinib by study of 14-day BID dosing of pacritinib in subjects with moderate and severe hepatic impairment compared to healthy matched control subjects with normal liver function. Safety and tolerability of multiple day dosing of pacritinib in the subject populations will also be evaluated.
This is a Phase 1, multi-center, open-label, multiple-dose, parallel-group study designed to assess the effect of hepatic insufficiency on the PK of 200 mg BID pacritinib. A total of approximately 22 to 32 subjects are planned, with approximately 8 moderate hepatically impaired subjects, approximately 6 to 8 severe hepatically impaired subjects, and approximately 8 to 16 healthy subjects with normal hepatic function. The primary objective of this study is to characterize and compare the steady-state PK profile of multiple doses (14 days) of 200 mg BID pacritinib in the study population, and the secondary objective is to evaluate the safety and tolerability of multiple doses (14 days) of 200 mg BID pacritinib. The study will consist of a screening period (Day -28 to Day -2), check-in (Day -1), a confinement period including treatment period (Day 1 through Day 14) and post-treatment period (Day 15 through Day 20), followed by a discharge visit (Day 21), and an EOS follow-up telephone call (Day 44). Serial blood samples for PK analysis of pacritinib will be collected pre dose through Day 21 at protocol-specified timepoints CK 18 will be collected . Safety and tolerability will be assessed by AEs, clinical laboratory tests, vital will occur 4 and 24 hours after the AM dose on Day 1, Day 10, Day 12, and Day 14 signs, ECGs, and physical examinations. ;
| 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 |