Clinical Trials /

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

NCT04831944

Description:

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.

Related Conditions:
  • Cancer
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: 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

Clinical Trial IDs

  • ORG STUDY ID: INCB 50465-108
  • NCT ID: NCT04831944

Conditions

  • Advanced Malignancies

Interventions

DrugSynonymsArms
parsaclisibINCB050465Treatment Group 1 : Severe hepatic impairment

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Treatment Group 1 : Severe hepatic impairmentExperimentalChild Pugh (CP) assessment score of 10-14 points
  • parsaclisib
Treatment Group 2 : Moderate hepatic impairmentExperimentalChild Pugh (CP) assessment score of 7-9 points
  • parsaclisib
Treatment Group 3 : Mild hepatic impairmentExperimentalChild Pugh (CP) assessment score of 5-6 points
  • parsaclisib
Treatment Group 4 : Normal hepatic impairmentExperimentalNormal hepatic function
  • parsaclisib

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
      
Maximum Eligible Age:80 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:Accepts Healthy Volunteers

Primary Outcome Measures

Measure:Pharmacokinetics Parameter : Cmax of parsaclisib
Time Frame:5 Days
Safety Issue:
Description:Maximum Observed Plasma Concentration of parsaclisib

Secondary Outcome Measures

Measure:Number of Treatment Emergent Adverse Events (TEAE)
Time Frame:Up to10 Days
Safety Issue:
Description:Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.
Measure:Pharmacokinetics Parameter : tmax of parsaclisib
Time Frame:5 Days
Safety Issue:
Description:Time to reach maximum plasma concentration of parsaclisib
Measure:Pharmacokinetics Parameter : t1/2 of parsaclisib
Time Frame:5 Days
Safety Issue:
Description:Apparent terminal phase disposition half-life of parsaclisib
Measure:Pharmacokinetics Parameter : CL/F of parsaclisib
Time Frame:5 Days
Safety Issue:
Description:Oral dose clearance of parsaclisib
Measure:Pharmacokinetics Parameter : Vz/F of parsaclisib
Time Frame:5 Days
Safety Issue:
Description:Apparent oral dose volume of distribution of parsaclisib

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Incyte Corporation

Trial Keywords

  • Hepatic Impairment
  • parsaclisib

Last Updated

April 22, 2021