to evaluate the safety, and pharmacokinetics of parscaclisib in participants with normal hepatic function and hepatic impairment.

Conditions: Advanced Malignancies

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

Keywords: hepatic impairment parsaclisib