A Phase 1, Open-Label Evaluation of the Pharmacokinetics and Safety of a Single Dose of Apraglutide in Subjects With Normal and Impaired Hepatic Function

The primary objective is to assess the PK of apraglutide in subjects with hepatic impairment compared with matched control subjects with normal hepatic function following single SC dose administration.

Inclusion Criteria:All Participants:Age between 18 and 75 years inclusiveSubjects who are willing and able to comply with the study proceduresSubjects able to understand and willing to sign the informed consentBody mass index (BMI) of ≥18 to ≤35 kg/m2; and a total body weight of >50 kg (110 lb).Women of childbearing potential (WOCBP) on highly effective method of contraception during the trial and for 1 month after the end of trial (EOT) visit. Sterilized or infertile or postmenopausal females.Male subjects with a female partner of childbearing potential: highly effective methods of contraception and no sperm donation during the trial and for 1 month after (EOT) visit.Participants with impaired hepatic function:Confirmed and documented diagnosis of cirrhosisModerate liver disease (Child-Pugh B): clinically stable for at least 1 month prior to screeningMild liver disease (Child-Pugh A): clinically stable for at least 1 month prior to screeningExclusion Criteria:History of clinically significant GI, bronchopulmonary, neurological, cardiovascular, endocrine, or allergic diseaseKnown hypersensitivity to the investigational medicinal product (IMP), any of their excipients or drugs of the same classIf capable of reproduction, unwilling to use an effective form of contraceptionIf a female of child-bearing potential, a positive urine/blood pregnancy testBreast-feeding womenPositive urine/blood test for alcohol and drugs of abuse at Screening and on Day-1Use of prohibited medications or herbal remediesKnown presence or history of intestinal polypsKnown presence or history of any type of cancerPancreatic events such as acute pancreatitis, pancreatic duct stenosis, pancreas infection, and increased blood amylase and lipase (>2.0-5.0×upper limit of normal range)Participation in an investigational drug or device study within 30 days prior to ScreeningDonation of blood over 500 mL within 2 months prior to ScreeningHeavy use of tobacco products (i.e., smokes more than 10 cigarettes per day)Concomitant disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this trialAny intercurrent clinically significant illness in the previous 28 days before Day 1 of this studyPositive blood screen for human immunodeficiency virus (HIV) antigen/antibody combo, hepatitis A (HAV), hepatitis B surface antigen (HBsAgB), or hepatitis C virus (HCV)Unwillingness or inability to comply with the study protocol for any other reason