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

NCT04831944 | Completed Phase 1 FDA Drug

• 1 other identifier: INCB 50465-108
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 5

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.

Conditions

Advanced Malignancies

Keywords

Hepatic Impairment; parsaclisib

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Number of Treatment Emergent Adverse Events (TEAE)

  Up to10 Days

• Pharmacokinetics Parameter : tmax of parsaclisib

  5 Days

• Pharmacokinetics Parameter : t1/2 of parsaclisib

  5 Days

• Pharmacokinetics Parameter : CL/F of parsaclisib

  5 Days

• Pharmacokinetics Parameter : Vz/F of parsaclisib

  5 Days

Study Arms (4)

Treatment Group 1 : Severe hepatic impairment

EXPERIMENTAL

Child Pugh (CP) assessment score of 10-14 points

Drug: parsaclisib

Treatment Group 2 : Moderate hepatic impairment

EXPERIMENTAL

Child Pugh (CP) assessment score of 7-9 points

Drug: parsaclisib

Treatment Group 3 : Mild hepatic impairment

EXPERIMENTAL

Child Pugh (CP) assessment score of 5-6 points

Drug: parsaclisib

Treatment Group 4 : Normal hepatic impairment

EXPERIMENTAL

Normal hepatic function

Drug: parsaclisib

Interventions

parsaclisib DRUG

parsaclisib will be administered orally after 8 hours of fasting.

Also known as: INCB050465

Treatment Group 1 : Severe hepatic impairment; Treatment Group 2 : Moderate hepatic impairment; Treatment Group 3 : Mild hepatic impairment; Treatment Group 4 : Normal hepatic impairment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (5)

Inland Empire Liver Foundation

Rialto, California, 92377, United States

Location

Orange County Research Center

Tustin, California, 92780, United States

Location

Clinical Pharmacology of Miami

Hialeah, Florida, 33014, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

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

San Antonio, Texas, 78215, United States

Location

MeSH Terms

Interventions

parsaclisib

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2021
• First Posted: April 5, 2021
• Study Start: March 29, 2021
• Primary Completion: March 10, 2022
• Study Completion: March 11, 2022
• Last Updated: August 26, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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.

Locations

US (5)