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

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

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.

Study Overview

• Status: Completed
• Conditions: Advanced Malignancies
• Intervention / Treatment: Drug: parsaclisib

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Rialto, California, United States, 92377
      • Inland Empire Liver Foundation
    • Tustin, California, United States, 92780
      • Orange County Research Center
  • Florida
    • Hialeah, Florida, United States, 33014
      • Clinical Pharmacology of Miami
    • Orlando, Florida, United States, 32809
      • Orlando Clinical Research Center
  • Texas
    • San Antonio, Texas, United States, 78215
      • Texas Liver Institute Tli the Liver Institute of South Texas List Downtown Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Treatment Group 1 : Severe hepatic impairment; Child Pugh (CP) assessment score of 10-14 points	Drug: parsaclisib; parsaclisib will be administered orally after 8 hours of fasting.; Other Names: INCB050465
EXPERIMENTAL: Treatment Group 2 : Moderate hepatic impairment; Child Pugh (CP) assessment score of 7-9 points	Drug: parsaclisib; parsaclisib will be administered orally after 8 hours of fasting.; Other Names: INCB050465
EXPERIMENTAL: Treatment Group 3 : Mild hepatic impairment; Child Pugh (CP) assessment score of 5-6 points	Drug: parsaclisib; parsaclisib will be administered orally after 8 hours of fasting.; Other Names: INCB050465
EXPERIMENTAL: Treatment Group 4 : Normal hepatic impairment; Normal hepatic function	Drug: parsaclisib; parsaclisib will be administered orally after 8 hours of fasting.; Other Names: INCB050465

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics Parameter : Cmax of parsaclisib	Maximum Observed Plasma Concentration of parsaclisib	5 Days
Pharmacokinetics Parameter : AUC 0-∞ of parsaclisib	Area Under the Concentration-time Curve From 0 to Infinity of parsaclisib	5 Days
Pharmacokinetics Parameter : AUC(0-t) of parsaclisib	Area Under the concentration- time curve up to the last measurable concentration of parsaclisib	5 Days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Incyte Corporation

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 29, 2021
• Primary Completion (ACTUAL): March 10, 2022
• Study Completion (ACTUAL): March 11, 2022

Study Registration Dates

• First Submitted: April 2, 2021
• First Submitted That Met QC Criteria: April 2, 2021
• First Posted (ACTUAL): April 5, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 26, 2022
• Last Update Submitted That Met QC Criteria: August 25, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Hepatic Impairment; parsaclisib
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Neoplasms
• Other Study ID Numbers: INCB 50465-108

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

• IPD Sharing Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• IPD Sharing Access Criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No