Clinical trial NCT04831944: To Evaluate the Safety, and Pharmacokinetics of Parscaclisib in Participants With Normal Hepatic Function and Hepatic Impairment.
Official title: A Phase 1, Open-Label Study to Evaluate the Pharmacokinetics and Safety of Parsaclisib in Participants With Normal Hepatic Function and Participants With Hepatic Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Malignancies
Keywords: Hepatic Impairment
parsaclisib
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2021-04-05
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of the study is to evaluate the pharmacokinetics and safety of parsaclisib in participants With normal hepatic function and participants with hepatic impairment.


Eligibility criteria: Inclusion Criteria:

* Participants with hepatic impairment.
* Participants eligible for Group 4 should be in good health.
* Participants eligible for Groups 1 through 3 may have medical findings consistent with their degree of hepatic dysfunction.
* Participants with abnormal findings considered not clinically significant by the investigator are eligible.
* Body mass index within the range of 18.0 to 40.0 kg/m2 (inclusive) at screening.
* Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

* Evidence of rapidly deteriorating hepatic function.
* Participants with serum calcium and phosphorus levels over the upper limits of the institutional normal ranges.
* History or current diagnosis of uncontrolled or significant cardiac disease indicating significant risk of safety for participation in the study, including any of the following:
* Participants who have a current, functioning organ transplant or have a scheduled organ transplant in the next 6 weeks from check-in.
* History of malignancy within 5 years of screening, with the exception of cured basal cell carcinoma, squamous cell carcinoma of the skin, ductal carcinoma in situ, or Gleason 6 prostate cancer.
* History of clinically significant gastrointestinal disease or surgery (cholecystectomy and appendectomy are allowed) that could impact the absorption of study drug.
* Participants with severe ascites or an encephalopathy ≥ Grade 2.
* Any major surgery within 4 weeks of screening.
* Donation of blood to a blood bank within 4 weeks of screening (within 2 weeks for plasma only).
* Blood transfusion within 4 weeks of check-in. Current or recent history (within 30 days before screening) of a clinically significant bacterial, fungal, parasitic, or mycobacterial infection, or currently receiving systemic antibiotics. Current clinically significant viral infection at screening or check-in.
* Positive serology for hepatitis B virus (eg, hepatitis B surface antigen) or human immunodeficiency virus. Participants whose results are compatible with immunity due to infection or prior immunization for hepatitis B may be included at the discretion of the investigator.
* History of alcoholism within 3 months of screening.
* Positive breath test for ethanol or positive urine screen for drugs of abuse that is not otherwise explained by permitted concomitant medications.
* Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) of study drug administration with another investigational medication or current enrollment in another investigational drug protocol.
* Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) of study drug administration with strong or moderate inducer or potent inhibitor of CYP3A4.
* Receipt of live (including attenuated) vaccines or anticipation of need for such a vaccine during the study. (Note: Non-live or inactivated vaccines allowed up to 2 weeks before first dose administration.)
* Known hypersensitivity or severe reaction to parsaclisib or excipients of parsaclisib.
* History of any significant drug allergy (such as anaphylaxis or hepatotoxicity) deemed clinically relevant by the investigator. Inability to be venipunctured or tolerate venous access.
* Participants eligible for Group 4 who have a history or presence of liver disease or liver injury as indicated by an abnormal clinically significant liver function profile at screening or check-in.
* Participants eligible for Group 4 who have a positive test for hepatitis C virus.
* Participants eligible for Group 4 who used tobacco- or nicotine-containing products within 6 months of screening.
* Women who are pregnant or breastfeeding

Primary outcomes:
measure: Pharmacokinetics Parameter : Cmax of parsaclisib
timeFrame: 5 Days
measure: Pharmacokinetics Parameter : AUC 0-∞ of parsaclisib
timeFrame: 5 Days
measure: Pharmacokinetics Parameter : AUC(0-t) of parsaclisib
timeFrame: 5 Days
Secondary outcomes:
measure: Number of Treatment Emergent Adverse Events (TEAE)
timeFrame: Up to10 Days
measure: Pharmacokinetics Parameter : tmax of parsaclisib
timeFrame: 5 Days
measure: Pharmacokinetics Parameter : t1/2 of parsaclisib
timeFrame: 5 Days
measure: Pharmacokinetics Parameter : CL/F of parsaclisib
timeFrame: 5 Days
measure: Pharmacokinetics Parameter : Vz/F of parsaclisib
timeFrame: 5 Days
Other outcomes:
Locations:
city: Rialto
country: United States
facility: Inland Empire Liver Foundation
state: California
city: Tustin
country: United States
facility: Orange County Research Center
state: California
city: Hialeah
country: United States
facility: Clinical Pharmacology of Miami
state: Florida
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
city: San Antonio
country: United States
facility: Texas Liver Institute Tli the Liver Institute of South Texas List Downtown Office
state: Texas
Study officials:
References: