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

• ClinicalTrials.gov Identifier: NCT04831944
• Recruitment Status: Recruiting
• First Posted: April 5, 2021
• Last Update Posted: March 2, 2022
• Sponsor: Incyte Corporation
• Information provided by (Responsible Party): Incyte Corporation

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Advanced Malignancies	Drug: parsaclisib	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• 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
• Actual Study Start Date: March 29, 2021
• Estimated Primary Completion Date: March 9, 2022
• Estimated Study Completion Date: March 9, 2022

Arms and Interventions

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 Name: 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 Name: 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 Name: INCB050465
Experimental: Treatment Group 4 : Normal hepatic impairment; Normal hepatic function	Drug: parsaclisib; parsaclisib will be administered orally after 8 hours of fasting.; Other Name: INCB050465

Outcome Measures

Primary Outcome Measures :

1. Pharmacokinetics Parameter : Cmax of parsaclisib [ Time Frame: 5 Days ]
   Maximum Observed Plasma Concentration of parsaclisib
2. Pharmacokinetics Parameter : AUC 0-∞ of parsaclisib [ Time Frame: 5 Days ]
   Area Under the Concentration-time Curve From 0 to Infinity of parsaclisib
3. Pharmacokinetics Parameter : AUC(0-t) of parsaclisib [ Time Frame: 5 Days ]
   Area Under the concentration- time curve up to the last measurable concentration of parsaclisib

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Contacts

Contact: Incyte Corporation Call Center (US); 1.855.463.3463; medinfo@incyte.com

Contact: Incyte Corporation Call Center (ex-US); +800 00027423; eumedinfo@incyte.com

Locations

United States, California

Inland Empire Liver Foundation; Recruiting

Rialto, California, United States, 92377

Orange County Research Center; Recruiting

Tustin, California, United States, 92780

United States, Florida

Clinical Pharmacology of Miami; Recruiting

Hialeah, Florida, United States, 33014

Orlando Clinical Research Center; Recruiting

Orlando, Florida, United States, 32809

United States, Texas

Texas Liver Institute Tli the Liver Institute of South Texas List Downtown Office; Recruiting

San Antonio, Texas, United States, 78215

Sponsors and Collaborators

Incyte Corporation

More Information

• Responsible Party: Incyte Corporation
• ClinicalTrials.gov Identifier: NCT04831944
• Other Study ID Numbers: INCB 50465-108
• First Posted: April 5, 2021
• Last Update Posted: March 2, 2022
• Last Verified: February 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

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

• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP)
• Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• 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.
• URL: https://www.incyte.com/our-company/compliance-and-transparency

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Incyte Corporation:

Hepatic Impairment; parsaclisib

Additional relevant MeSH terms:

Neoplasms