To Evaluate the Safety, and Pharmacokinetics of Parscaclisib in Participants With Normal Hepatic Function and Hepatic Impairment.

• Status: Recruiting
• Trial end date: 2021-12-29
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Incyte Corporation

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