A Study to Evaluate ASP0367 in Participants With Mild/Moderate Hepatic Impairment Compared to Participants With Normal Hepatic Function

Completed · Phase 1

Conditions studied: Hepatic Impairment, Healthy Volunteers

In brief

The purpose of this study is to evaluate the effect of ASP0367 in participants with mild and moderate hepatic impairment compared to healthy participants with normal hepatic function. The study will also evaluate the safety and tolerability of ASP0367 in participants with mild and moderate hepatic impairment compared to healthy participants with normal hepatic function.

Key facts

Study ID

NCT04942964

Run by

Astellas Pharma Global Development, Inc.

People needed

25

Starts

2021-09-13

Expected to finish

2022-01-20

Last updated by the study team

2024-10-21

Who can join

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

You may qualify if…

• Participant has a BMI range of 18.5 to 36.0 kg/m\^2, inclusive and weighs at least 50 kg at screening.
• Female participant is not pregnant and at least 1 of the following conditions apply:
• Not a woman of childbearing potential (WOCBP)
• WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 28 days after IP administration.
• Female participant must agree not to breastfeed starting at screening and throughout the study period and for 28 days after IP administration.
• Female participant must not donate ova starting at dose of IP and throughout the study period and for 28 days after IP administration.
• Male participant with female partner(s) of childbearing potential (including breastfeeding partner[s]) must agree to use contraception throughout the study period and for 28 days after IP administration.
• Male participant must not donate sperm during the study period and for 28 days after 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 28 days after IP administration.
• Participant agrees not to participate in another interventional study while participating in the present study.
• Additional Criteria for Participants with Hepatic Impairment:
• Participant has mild (Child-Pugh classification Class A, score 5 or 6) or moderate (Child-Pugh classification Class B, score 7 to 9) hepatic impairment at screening

You may not qualify if…

• Participant has received any investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to day -1.
• Participant has had a partial hepatectomy within 1 year prior to screening.
• Participant has any condition which makes the participant unsuitable for study participation.
• Participant has a known or suspected hypersensitivity to ASP0367 or any components of the formulation used.
• Participant has received a COVID-19 vaccine within the 2 weeks prior to IP administration or will have a COVID-19 vaccine dose before the ESV.
• Female participant who has been pregnant within 6 months prior to screening or breastfeeding within 3 months prior to screening.
• Participant has had previous exposure with ASP0367.
• Participant has used moderate or strong inducers of CYP3A within the 3 months prior to day -1.
• Participant has used proton-pump inhibitors within the 2 weeks prior to IP administration.
• Participant has used Histamine-2 blockers within 24 hours prior to IP administration.
• 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 (excluding chronic hepatitis B virus and hepatitis C virus), bacterial (including upper respiratory infection) or fungal (noncutaneous) infection within 1 week 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 is an employee of Astellas, the study-related CROs or the clinical unit.
• Participant has a positive result for SARS-CoV-2 test at screening.
• Participant has creatinine level outside normal limits on day -1. In such a case, the assessment may be repeated once.
• Additional Criteria for Participants with Hepatic Impairment:
• Participant has any history or evidence of any clinically significant cardiovascular, gastrointestinal, endocrinologic, hematologic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major disease or malignancy not related to current disease state.
• Participant has cardiac troponin I (cTnI) > upper limit of normal (ULN) (or cardiac troponin T [cTnT]) > ULN if cTnI is not available). In such a case, the assessment may be repeated once.
• Participant has a mean pulse < 45 or > 100 bpm; mean systolic blood pressure > 160 mmHg; mean diastolic blood pressure > 100 mmHg (measurements taken in triplicate after participant has been resting in the supine position for at least 5 minutes; pulse will be measured automatically) on day -1. If the mean blood pressure exceeds the limits above, 1 additional triplicate may be taken.
• Participant has a mean QT interval using Fridericia's correction (QTcF) of > 460 msec for male participants and > 480 msec for female participants on day -1. If the mean QTcF exceeds the limits above, 1 additional triplicate ECG may be taken.
• Participant who has had a change in dose regimen of medically required medication(s) in the 2 weeks prior to screening (permitted concomitant medications) and/or participant for whom dose changes are likely to occur during the study (minor dose changes are allowed in agreement with the sponsor) and/or participant has used nonpermitted concomitant medication(s) in the 3 weeks prior to admission to the clinical unit (nonpermitted concomitant medications include any known hepatic enzyme-altering agents, compounds, vitamins or natural herbal remedies, e.g., St. John's Wort known to restrict metabolism).
• Participant has a history of consuming > 14 units for male participants and > 7 units for female participants of alcoholic beverages per week within 3 months prior to screening or has a history of alcoholism 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 drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine and/or opiates) within 3 months prior to day -1 or the participant tests positive for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine and opiates) at screening or on day -1, unless the positive test is due to prescription drug use that is approved by the principal investigator and sponsor.
• Participant has a positive serology test for hepatitis A virus antibodies (IgM), hepatitis B surface antigen (HBsAg) or antibodies to human immunodeficiency virus type 1 and/or type 2 at screening.

Where it is running

• Advanced Pharma CR, LLC — Miami, Florida, United States
• Orlando Clinical Research Center, Inc — Orlando, Florida, United States
• Texas Liver Institute — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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