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

NCT04831996 | Completed Phase 1 FDA Drug

• 1 other identifier: INCB 50465-109
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Advanced Malignancies

Outcome Measures

Primary Outcomes (6)

• Pharmacokinetics Parameter Groups1-4 : Cmax of parsaclisib

  Maximum Observed Plasma Concentration of parsaclisib

  4 Days

• Pharmacokinetics Parameter Groups 1-4 : AUC 0-∞ of parsaclisib

  Area Under the Concentration-time Curve From 0 to Infinity of parsaclisib

  4 Days

• Pharmacokinetics Parameter Groups 1-4 : AUC(0-t) of parsaclisib

  Area Under the concentration- time curve up to the last measurable concentration of parsaclisib

  4 Days

• Pharmacokinetics Parameter Group 5: Cmax of parsaclisib

  Maximum Observed Plasma Concentration of parsaclisib

  4 Days for period 1 and 2

• Pharmacokinetics Parameter Group 5 : AUC 0-∞ of parsaclisib

  Area Under the Concentration-time Curve From 0 to Infinity of parsaclisib

  4 Days for period 1 and 2

• Pharmacokinetics Parameter Group 5: AUC(0-t) of parsaclisib

  Area Under the concentration- time curve up to the last measurable concentration of parsaclisib

  4 Days for period 1 and 2

Secondary Outcomes (11)

• Number of Treatment Emergent Adverse Events (TEAE) Groups 1-4

  up to 11 Days

• Pharmacokinetics Parameter Groups 1-4 : tmax of parsaclisib

  4 Days

• Pharmacokinetics Parameter Groups 1-4 : t1/2 of parsaclisib

  4 Days

• Pharmacokinetics Parameter Groups 1-4 : CL/F of parsaclisib

  4 Days

• Pharmacokinetics Parameter Groups 1-4 : Vz/F of parsaclisib

  4 Days

Study Arms (5)

Treat Group 1 : Normal Renal Function

EXPERIMENTAL

eGFR: ≥ 90 mL/min/1.73 m\^2

Drug: parsaclisib

Treat Group 2 : Mild Renal Impairment

EXPERIMENTAL

eGFR: 60-89 mL/min/1.73 m\^2

Drug: parsaclisib

Treat Group 3 : Moderate Renal Impairment

EXPERIMENTAL

eGFR: 30-59 mL/min/1.73 m\^2

Drug: parsaclisib

Treat Group 4 : Severe Renal Impairment

EXPERIMENTAL

eGFR: 15-29 mL/min/1.73 m\^2 and not on Hemo Dialysis

Drug: parsaclisib

Treat Group 5 : Kidney Failure

EXPERIMENTAL

eGFR: \< 15 mL/min/1.73 m\^2 on Hemo Dialysis

Drug: parsaclisib

Interventions

parsaclisib DRUG

parsaclisib will be administered orally after 8 hours of fasting.

Also known as: INCB050465

Treat Group 1 : Normal Renal Function; Treat Group 2 : Mild Renal Impairment; Treat Group 3 : Moderate Renal Impairment; Treat Group 4 : Severe Renal Impairment; Treat Group 5 : Kidney Failure

Eligibility Criteria

• Age: 18 Years - 82 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Body 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.

You may not qualify if:

• 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
• (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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (4)

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

Prism Research

Saint Paul, Minnesota, 55114, United States

Location

MeSH Terms

Interventions

parsaclisib

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Open Label
• 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: May 4, 2021
• Primary Completion: July 8, 2022
• Study Completion: July 8, 2022
• Last Updated: August 17, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• 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 (4)