| Eligibility |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
- Participant has fluctuating or rapidly deteriorating hepatic function, as indicated by
strongly varying or worsening of clinical and/or laboratory signs of hepatic
impairment within the screening period (e.g., advanced ascites, infection of ascites,
fever, active gastrointestinal bleeding).
- Participant has a presence of a hepatocellular carcinoma, or an acute liver disease
caused by an infection or drug toxicity.
- Participant has severe portal hypertension or surgical portosystemic shunts, including
transjugular intrahepatic portosystemic shunt.
- Participant has biliary liver cirrhosis, biliary obstruction or other cause of hepatic
impairment not related to parenchymal disorder and/or disease of the liver.
- Participant has signs of significant hepatic encephalopathy (hepatic encephalopathy
grade = 2).
- Participant has severe ascites and/or pleural effusion.
- Participant has esophageal or gastric varices which have a high risk of clinically
significant hemorrhage.
- Participant has thrombocyte level below 40 × 10^9/L and/or hemoglobin < 90 g/L.
- Participant has had previous liver transplantation.
Additional Criteria for Healthy Participants with Normal Hepatic Function:
- Participant has any of the liver function tests (alkaline phosphatase, alanine
aminotransferase, aspartate aminotransferase and total bilirubin) = 1 × ULN or
international normalized ratio > 1.1 on day -1. In such a case, the assessment may be
repeated once.
- Participant has cTnI > ULN (or cTnT > ULN if cTnI is not available) at screening.
- Participant has any history or evidence of any clinically significant cardiovascular,
gastrointestinal, endocrinologic, hematologic, hepatic, immunologic, metabolic,
urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major
disease or malignancy.
- Participant has any clinically significant abnormality following the physical
examination, ECG and protocol-defined clinical laboratory tests at screening or on day
-1.
- Participant has a mean pulse < 45 or > 90 bpm; mean SBP > 150 mmHg; mean DBP > 90 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 QTcF of > 430 msec for male participants > 450 msec for female
participants on day -1. If the mean QTcF exceeds the limits above, 1 additional
triplicate ECG may be taken.
- Participant has used any prescribed or nonprescribed drugs (including vitamins and
natural and herbal remedies, e.g., St. John's Wort) in the 2 weeks prior to IP
administration, except for occasional use of acetaminophen (up to 2 g/day), topical
dermatological products (including corticosteroid products), hormonal contraceptives
and hormone replacement therapy.
- Participant has a history of consuming > 14 units for male participants and > 7 units
for female participants of alcoholic beverages per week within 6 months prior to
screening or has a history of alcoholism or drug/chemical/substance abuse within 2
years 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.
- Participant has a positive serology test for HAV antibodies (IgM), hepatitis B surface
antigen, HCV antibodies or antibodies to HIV type 1 and/or type 2 at screening.
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