A Study to Investigate the Effect of Severe Renal Impairment on Gilteritinib Compared to Healthy Participants With Normal Renal Function

Completed · Phase 1

Conditions studied: Renal Impaired, Gilteritinib, Normal Renal Function, Pharmacokinetics of ASP2215

In brief

The purpose of the study was to evaluate the pharmacokinetics of a single oral dose of gilteritinib in male and female participants with severe renal impairment compared to healthy male and female participants with normal renal function. This study also evaluated safety and tolerability of a single oral dose of gilteritinib in male and female participants with severe renal impairment and healthy male and female participants with normal renal function. Part 2 of the study (mild and moderate renal impairment) was not conducted based on the final pharmacokinetic findings from part 1 (severe renal impairment).

Key facts

Study ID

NCT04699877

Run by

Astellas Pharma Global Development, Inc.

People needed

17

Starts

2021-01-28

Expected to finish

2022-07-18

Last updated by the study team

2024-11-05

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Participant is eligible for participation in the study if all of the following apply:
• Participant has body mass index (BMI) range of 18.5 to 40.0 kg/m\^2, inclusive and weighs at least 50 kg at screening.
• Female participant is not pregnant and the following condition apply: Not a woman of childbearing potential (WOCBP)
• Male participant with female partner(s) of childbearing potential (including breastfeeding partner) must agree to use contraception throughout the treatment period and for 120 days after Investigational Product (IP) administration.
• Male participant must not donate sperm during the treatment period and for 120 days after investigational product (IP) administration.
• Male participant with pregnant partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy throughout the study period and for 120 days after IP administration.
• Participant has renal function defined by estimated glomerular filtration rate (eGFR) using modification of diet in renal disease (MDRD) formula:
• Normal renal function with eGFR ≥ 90 mL/min per 1.73 m\^2, or
• Mild renal impairment with eGFR 60 to <90 mL/min per 1.73 m\^2, or
• Moderate renal impairment with eGFR 30 to <60 mL/min per 1.73 m\^2, or
• Severe renal impairment as defined by the National Kidney Foundation and by eGFR <30 mL/min per 1.73 m\^2 and not on hemodialysis (preferably not higher than 20 mL/min per 1.73 m\^2, with at least 50% of participants required to have eGFR ≤ 20 mL/min per 1.73 m\^2).
• Participant has adequate venous access to allow collection of study-related samples.
• Participant agrees not to participate in another interventional study while participating in the present study.

You may not qualify if…

• Participant will be excluded from participation in the study if any of the following apply:
• Participant has received any investigational therapy within 28 days or 7 half-lives, whichever is longer, prior to day -1.
• Participant has any condition which makes the participant unsuitable for study participation.
• Female participant who has been pregnant within 6 months prior to screening or breastfeeding within 3 months prior to screening.
• Participant has a known or suspected hypersensitivity to gilteritinib or any components of the formulation used.
• Participant has had previous exposure with gilteritinib.
• Participant has any of the liver function tests (alkaline phosphatase [ALP], alanine aminotransferase [ALT], aspartate aminotransferase [AST] and total bilirubin [TBL]) ≥ 1.5 × upper limit of normal on day -1. In such a case, the assessment may be repeated once.
• Participant has any clinically significant history of allergic conditions (including drug allergies, asthma, eczema or anaphylactic reactions, but excluding untreated, asymptomatic, seasonal allergies) prior to IP administration.
• Participant has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection) or fungal (noncutaneous) infection within 1 week prior to day -1.
• Participant has a mean corrected QT interval using Fridericia's formula (QTcF) of > 450 msec (for male and female participants) on day -1. If the mean QTcF exceeds the limits above, 1 additional triplicate 12-lead electrocardiogram (ECG) may be taken.
• Participant has a history of smoking more than 10 cigarettes (or equivalent amount of tobacco) per day within 3 months prior to day -1.
• Participant has a history of consuming > 14 units for male participants or > 7 units for female participants of alcoholic beverages per week within 6 months prior to screening or has a history of alcoholism 3 months prior to screening or drug/chemical/ substance abuse within 1 year prior to screening (note: 1 unit = 12 ounces of beer, 4 ounces of wine, 1 ounce of spirits/hard liquor) or the participant tests positive for alcohol at screening or on day -1.
• Participant has used any inducer of cytochrome P450 (CYP)3A metabolism (e.g., St. John's Wort, barbiturates and rifampin) in the 3 months prior to day -1.
• Participant has had significant blood loss, donated ≥ 1 unit (450 mL) of whole blood or donated plasma within 7 days prior to day -1 and/or received a transfusion of any blood or blood products within 60 days.
• Participant has a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease or a family history of long QT syndrome.
• Participant has a positive serology test for hepatitis A virus immunoglobulin M antibodies, hepatitis B surface antigen, hepatitis C virus antibodies or antibodies to human immunodeficiency virus type 1 and/or type 2 at screening. Participants with isolated hepatitis B core antibody (with negative hepatitis B surface antigen and negative hepatitis B surface antibody) may be eligible if hepatitis B DNA or hepatitis C RNA is undetectable.
• Participant is an employee of Astellas, the study-related contract research organizations (CROs) or the clinical unit.
• Participant who has received any of the following drugs/products within 2 weeks prior to IP administration:
• Strong or moderate CYP3A inhibitors (e.g., grapefruit, Seville oranges, ketoconazole or fluconazole)
• Strong or moderate inhibitors and all inducers of P-glycoprotein
• Substrates of multidrug and toxin extrusion 1
• Drugs that target serotonin 5-hydroxytryptamine receptor 1 or 5-hydroxytryptamine receptor 2B
• Participant has a positive result for SARS-CoV-2 polymerase chain reaction (PCR) test during screening.
• Participant has clinical signs and symptoms consistent with COVID-19 infection, e.g., fever, dry cough, dyspnea, sore throat, muscle or body aches and gastrointestinal symptoms or confirmed infection by appropriate SARS-CoV-2 PCR test within the 4 weeks prior to screening.
• Additional criteria for participants with mild, moderate and severe renal impairment:

Where it is running

• National Institute of Clinical Research — Garden Grove, California, United States
• Orange County Research Institute — Tustin, California, United States
• Orlando Clinical Research Center — Orlando, Florida, United States
• Site BG35901 — Sofia, Bulgaria

Full record on ClinicalTrials.gov

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