Last updated on January 2020

Safety Tolerability and Pharmacodynamics of SYNB1020

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Fibrosis | Cirrhosis
  • Age: Between 18 - 75 Years
  • Gender: Male or Female

Key Inclusion Criteria:

  • Age 18 to 74 years
  • Females must be of non childbearing potential
  • Able and willing to complete informed consent process
  • Available for and agree to all study procedures
  • Screening laboratory evaluations within defined acceptable limits or judged to be not clinically significant by the Investigator
  • Diagnosis of chronic, stable, hepatic insufficiency with features of cirrhosis due to any etiology
  • Evidence of elevated portal hypertension by either liver stiffness measurement, the presence of abdominal or esophageal varices, splenomegaly or ascites (Part 2 only)
  • Elevated venous ammonia (Part 2 only)

Key Exclusion Criteria:

  • Body mass index < 18.5 or 40 kg/m2
  • Administration or ingestion of an investigational drug within 8 weeks or 5 half-lives, whichever is longer, prior to screening or current enrollment in an investigational study
  • Allergy to ranitidine or intolerance to any of the excipients (glycerol, CS Health Easy Fiber.
  • Any condition, prescription medication or over-the-counter product that may possibly affect absorption of medications or nutrients
  • Dependence on drugs of abuse
  • Apart from chronic liver disease, any acute or chronic medical, surgical, psychiatric, or social condition including history of cerebrovascular disease (stroke, transient ischemic attack) or dementia, or laboratory abnormality that may increase the patient risk associated with study participation, compromise adherence to study procedures and requirements, confound interpretation of the safety, kinetics, or pharmacodynamics results, and, in the judgment of the investigator, make the patient inappropriate for enrollment
  • Current of past HE of Grade 2 or higher requiring hospitalization
  • Child-Turcotte-Pugh score > 9
  • History of liver transplant

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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