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.
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
Interventions
Drug | Synonyms | Arms |
---|
parsaclisib | INCB050465 | Treatment 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
Name | Type | Description | Interventions |
---|
Treatment Group 1 : Severe hepatic impairment | Experimental | Child Pugh (CP) assessment score of 10-14 points | |
Treatment Group 2 : Moderate hepatic impairment | Experimental | Child Pugh (CP) assessment score of 7-9 points | |
Treatment Group 3 : Mild hepatic impairment | Experimental | Child Pugh (CP) assessment score of 5-6 points | |
Treatment Group 4 : Normal hepatic impairment | Experimental | Normal hepatic function | |
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