Clinical Trials /

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

NCT04831996

Description:

The purpose of the study is to evaluate the pharmacokinetics and safety of parsaclisib in participants With normal renal function and participants with renal 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 Renal Function and Renal Impairment.
  • Official Title: A Phase 1, Open-Label Study to Evaluate the Pharmacokinetics and Safety of Parsaclisib in Participants With Normal Renal Function and Participants With Renal Impairment

Clinical Trial IDs

  • ORG STUDY ID: INCB 50465-109
  • NCT ID: NCT04831996

Conditions

  • Advanced Malignancies

Interventions

DrugSynonymsArms
parsaclisibINCB050465Treat Group 1 : Normal Renal Function

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
Treat Group 1 : Normal Renal FunctionExperimentaleGFR: ≥ 90 mL/min/1.73 m^2
  • parsaclisib
Treat Group 2 : Mild Renal ImpairmentExperimentaleGFR: 60-89 mL/min/1.73 m^2
  • parsaclisib
Treat Group 3 : Moderate Renal ImpairmentExperimentaleGFR: 30-59 mL/min/1.73 m^2
  • parsaclisib
Treat Group 4 : Severe Renal ImpairmentExperimentaleGFR: ≤ 29 mL/min/1.73 m^2 and not on Hemo Dialysis
  • parsaclisib
Treat Group 5 : Kidney FailureExperimentaleGFR: ≤ 29 mL/min/1.73 m^2 and on Hemo Dialysis
  • parsaclisib

Eligibility Criteria

        Inclusion Criteria:

          -  Participants will be classified at screening by renal function based on eGFR as
             calculated by the MDRD formula and requirement for HD (Group 5).

          -  Participants eligible for Group 5 with ESRD have received HD for at least 3 months
             prior to screening.

          -  Participants eligible for Group 1 should be in good health as determined by no
             clinically significant deviations from normal for medical history, physical
             examination, vital signs, 12-lead ECGs, or clinical laboratory determinations at
             screening or Day -1.

          -  Participants eligible for Groups 2 through 5 may have medical findings consistent with
             their degree of renal dysfunction.

          -  Participants with abnormal findings considered not clinically significant by the
             medical monitor or investigator are eligible.

             0Body mass index within the range 18.0 to 40.0 kg/m2 (inclusive) at screening.

          -  Willingness to avoid pregnancy or fathering children.

          -  Ability to swallow and retain oral medication.

        Exclusion Criteria:

          -  History of uncontrolled or unstable cardiovascular, respiratory, hepatic,
             gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease
             within 6 months of screening. Evidence of rapidly deteriorating renal function.

          -  Participants who have a current, functioning organ transplant or have a scheduled
             organ transplant within 6 weeks after 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 eligible for Group 1 who have a history of renal disease or renal injury
             as indicated by an abnormal, clinically significant renal function profile at
             screening or Day -1.

          -  Participants eligible for Groups 2 through 5 who have had a change in disease status
             within 30 days of screening, as documented by the participant's medical history,
             deemed clinically significant by the investigator.

          -  History or current diagnosis of uncontrolled or significant cardiac disease indicating
             significant risk of safety for participation in the study.

          -  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 Day -1 (for Groups 1 through 4) or Period 1, Day

          -  1 (Group 5).

          -  Chronic or current active infectious disease requiring systemic antibiotic,
             antifungal, or antiviral treatment.

          -  Positive test for HBV (HBsAg, HBsAg antibody, and hepatitis B core antibody), HCV (HCV
             antibody), or HIV. Participants whose results are compatible with prior immunization
             for HBV may be included at the discretion of the investigator.

        Participants eligible for Group 1 who have used tobacco- or nicotine-containing products
        within 6 months of screening.

          -  Participants eligible for Groups 2 through 5 who smoke > 10 cigarettes per day or
             equivalent use of other tobacco- or nicotine-containing products and are unwilling to
             refrain from tobacco or nicotine use on dosing days and abide by CRU restrictions.

          -  Positive breath test for ethanol or positive urine or serum 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 study.

          -  Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) of
             study drug administration with strong or moderate inducer or inhibitor of CYP3A4,
             P-gp,or BCRP.

          -  For participants eligible for Group 1, use of prescription drugs within 14 days of
             study drug administration or nonprescription medications/products (including vitamins,
             minerals, and phytotherapeutic/herbal/plant-derived preparations) within 7 days of
             study drug administration. However, occasional paracetamol, ibuprofen, and
             standard-dose vitamins are permitted.

          -  For participants eligible for Groups 2 through 5, use of prescription drugs within 14
             days of study drug administration, with the exception of established therapy for renal
             disease and the treatment of associated disorders that have been stable for at least 7
             days prior to study drug administration, as approved by the investigator and in
             consultation with the sponsor's medical monitor.

          -  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.

          -  History of any significant drug allergy (such as anaphylaxis or hepatotoxicity) deemed
             clinically relevant by the investigator.

          -  Inability to undergo venipuncture or tolerate venous access.

          -  Participants eligible for Group 5 that are not expected to continue HD treatment for
             the duration of the study.

          -  Receipt of live (including attenuated) vaccines or anticipation of need for such a
             vaccine during the study (Note: nonlive or inactivated vaccines are allowed up to 2
             weeks prior to the first dose of study drug).

          -  Known hypersensitivity or severe reaction to parsaclisib or excipients of parsaclisib.

          -  History of alcoholism within 3 months of screening.

          -  Women who are pregnant or breastfeeding.
      
Maximum Eligible Age:82 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:Accepts Healthy Volunteers

Primary Outcome Measures

Measure:Pharmacokinetics Parameter Groups1-4 : Cmax of parsaclisib
Time Frame:4 Days
Safety Issue:
Description:Maximum Observed Plasma Concentration of parsaclisib

Secondary Outcome Measures

Measure:Number of Treatment Emergent Adverse Events (TEAE) Groups 1-4
Time Frame:up to 11 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 Groups 1-4 : tmax of parsaclisib
Time Frame:4 Days
Safety Issue:
Description:Time to reach maximum plasma concentration of parsaclisib
Measure:Pharmacokinetics Parameter Groups 1-4 : t1/2 of parsaclisib
Time Frame:4 Days
Safety Issue:
Description:Apparent terminal phase disposition half-life of parsaclisib
Measure:Pharmacokinetics Parameter Groups 1-4 : CL/F of parsaclisib
Time Frame:4 Days
Safety Issue:
Description:Oral dose clearance of parsaclisib
Measure:Pharmacokinetics Parameter Groups 1-4 : Vz/F of parsaclisib
Time Frame:4 Days
Safety Issue:
Description:Apparent oral dose volume of distribution of parsaclisib
Measure:Pharmacokinetics Parameter Group 5 : tmax of parsaclisib
Time Frame:4 Days for period 1 and 2
Safety Issue:
Description:Time to reach maximum plasma concentration of parsaclisib
Measure:Pharmacokinetics Parameter Group 5 : t1/2 of parsaclisib
Time Frame:4 Days for period 1 and 2
Safety Issue:
Description:Apparent terminal phase disposition half-life of parsaclisib
Measure:Pharmacokinetics Parameter Group 5 : CL/F of parsaclisib
Time Frame:4 Days for period 1 and 2
Safety Issue:
Description:Oral dose clearance of parsaclisib
Measure:Pharmacokinetics Parameter Group 5 : Vz/F of parsaclisib
Time Frame:4 Days for period 1 and 2
Safety Issue:
Description:Apparent oral dose volume of distribution of parsaclisib
Measure:Pharmacokinetics Parameter Group 5 during Dialysis - : AUC1-5 of parsaclisib
Time Frame:4 Days for period 1 and 2
Safety Issue:
Description:Area Under the Concentration-time Curve From 1 to 5 hrs. of parsaclisib
Measure:Number of Treatment Emergent Adverse Events (TEAE) Group 5
Time Frame:up to 18 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.

Details

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

Last Updated

May 18, 2021