This study will assess the pharmacokinetics of belapectin in subjects with mild, moderate, or severe hepatic impairment according to 3 different Child-Pugh categories: mild, moderate, or severe impairment, compared to matched healthy control subjects.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Males or females, of any race, between 18 and 75 years of age, inclusive.
. Body mass index between 18.0 and 45.0 kg/m2, inclusive.
. Females of childbearing potential will not be pregnant or lactating and must have a negative result on an approved pregnancy test at Screening and Check-in. Females of childbearing potential must agree to use contraception by a method of proven reliability (including abstinence) for the duration of the study.
. Males will agree to use contraception.
. Male subjects must not donate sperm from Check-in (Day -1) until 90 days after the Follow-up visit.
. Able to comprehend and willing to sign an informed consent form (ICF) and to abide by the study restrictions.
. In good health, determined by no clinically significant findings from medical history, physical examination, 12 lead electrocardiogram (ECG), vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia \[eg, suspicion of Gilbert's syndrome based on total and direct bilirubin\] is not acceptable) at Screening and Check in (Day -1), as assessed by the Investigator (or designee).
. Matched to subjects with mild, moderate, or severe hepatic impairment in sex, age (±10 years), and body mass index (BMI) (±20%).
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To Assess the PK AUC0-∞ of Belapectin Following a Single IV Dose of Belapectin in Subjects With Mild, Moderate, or Severe Hepatic Impairment, Compared to Healthy Subjects With Normal Hepatic Function.
Timeframe: Blood PK: Day -1 to 336 hours post dose
2
To Assess the PK AUC0-t of Belapectin Following a Single IV Dose of Belapectin in Subjects With Mild, Moderate, or Severe Hepatic Impairment, Compared to Healthy Subjects With Normal Hepatic Function.
Timeframe: Blood PK: Day -1 to 336 hours post dose
3
To Assess the PK Cmax of Belapectin Following a Single IV Dose of Belapectin in Subjects With Mild, Moderate, or Severe Hepatic Impairment, Compared to Healthy Subjects With Normal Hepatic Function.
Timeframe: Blood PK: Day -1 to 336 hours post dose
4
To Assess the PK t1/2 of Belapectin Following a Single IV Dose of Belapectin in Subjects With Mild, Moderate, or Severe Hepatic Impairment, Compared to Healthy Subjects With Normal Hepatic Function.
Timeframe: Blood PK: Day -1 to 336 hours post dose
. Significant history or clinical manifestation of any metabolic, allergic, dermatological, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee).
. Use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations within 7 days prior to Check-in, unless deemed acceptable by the Investigator (or designee).
. Alcohol consumption of \> 21 drinks per week for males and \> 14 drinks for females.
. Positive urine drug screen at Screening and/or Check in (Day -1), that is not otherwise explained by permitted concomitant medication or ingestion of poppy seeds, or positive alcohol test result (breath or urine in accordance with standard practice at each CRU) at Screening or Check-in (Day -1).
. Positive human immunodeficiency virus test.
. Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days, or 5 half-lives (whichever is longer), prior to dosing.
. Ingestion of Seville orange or grapefruit containing foods or beverages within 7 days prior to Check-in (Day -1).