To Evaluate the Safety, and Pharmacokinetics of Parscaclisib in Participants With Normal Hepatic Function and Hepatic Impairment.
- Registration Number
- NCT04831944
- Lead Sponsor
- Incyte Corporation
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment Group 1 : Severe hepatic impairment parsaclisib Child Pugh (CP) assessment score of 10-14 points Treatment Group 2 : Moderate hepatic impairment parsaclisib Child Pugh (CP) assessment score of 7-9 points Treatment Group 3 : Mild hepatic impairment parsaclisib Child Pugh (CP) assessment score of 5-6 points Treatment Group 4 : Normal hepatic impairment parsaclisib Normal hepatic function
- Primary Outcome Measures
Name Time Method Pharmacokinetics Parameter : Cmax of parsaclisib 5 Days Maximum Observed Plasma Concentration of parsaclisib
Pharmacokinetics Parameter : AUC 0-∞ of parsaclisib 5 Days Area Under the Concentration-time Curve From 0 to Infinity of parsaclisib
Pharmacokinetics Parameter : AUC(0-t) of parsaclisib 5 Days Area Under the concentration- time curve up to the last measurable concentration of parsaclisib
- Secondary Outcome Measures
Name Time Method Number of Treatment Emergent Adverse Events (TEAE) Up to10 Days Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.
Pharmacokinetics Parameter : tmax of parsaclisib 5 Days Time to reach maximum plasma concentration of parsaclisib
Pharmacokinetics Parameter : CL/F of parsaclisib 5 Days Oral dose clearance of parsaclisib
Pharmacokinetics Parameter : t1/2 of parsaclisib 5 Days Apparent terminal phase disposition half-life of parsaclisib
Pharmacokinetics Parameter : Vz/F of parsaclisib 5 Days Apparent oral dose volume of distribution of parsaclisib
Trial Locations
- Locations (5)
Inland Empire Liver Foundation
🇺🇸Rialto, California, United States
Orange County Research Center
🇺🇸Tustin, California, United States
Clinical Pharmacology of Miami
🇺🇸Hialeah, Florida, United States
Orlando Clinical Research Center
🇺🇸Orlando, Florida, United States
Texas Liver Institute Tli the Liver Institute of South Texas List Downtown Office
🇺🇸San Antonio, Texas, United States
Inland Empire Liver Foundation🇺🇸Rialto, California, United States