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Safety, Tolerability and Pharmacodynamics of SYNB1020

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03447730
Recruitment Status : Completed
First Posted : February 27, 2018
Last Update Posted : August 28, 2019
Information provided by (Responsible Party):

Brief Summary:
This is a phase 1b/2a, randomized, double-blinded, placebo-controlled study to evaluate the safety, tolerability and pharmacodynamics of SYNB1020 in hepatic insufficiency and cirrhosis patients.

Condition or disease Intervention/treatment Phase
Cirrhosis Drug: SYNB1020 Other: Placebo Phase 1 Phase 2

Detailed Description:

This study consists of two parts:

Part 1 (Completed):

A sentinel open-label cohort of subjects with cirrhosis and Model for End-Stage Liver Disease (MELD) score <12 will be admitted to an inpatient facility for a run in diet, baseline assessments, IP administration, safety monitoring, and collection of blood, urine, and fecal samples for evaluation of safety, tolerability, and pharmacokinetics and PD evaluations. Once the safety and tolerability have been established in Part 1, enrollment will be opened to subjects in Part 2.

Part 2:

Part 2 of the trial will comprise a randomized, double-blinded, placebo-controlled study in subjects with cirrhosis and hyperammonemia. Subjects may be pre screened for eligibility based on medical history and a single fasting spot venous ammonia measurement. Eligible subjects with elevated fasting spot venous ammonia will then undergo full screening within 7 days of pre screening. Eligible subjects will be admitted to an inpatient facility for a run-in diet and 24-hour ammonia profile, and those with an elevated 24-hour ammonia AUC will proceed with randomization, IP administration, safety monitoring, and collection of blood, urine, and fecal samples for pharmacokinetic and pharmacodynamic (PD) evaluations.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacodynamics of SYNB1020 in Hepatic Insufficiency and Cirrhosis Patients
Actual Study Start Date : March 16, 2018
Actual Primary Completion Date : August 20, 2019
Actual Study Completion Date : August 20, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

Arm Intervention/treatment
Experimental: SYNB1020
SYNB1020 (5 × 10 to the 11th CFU, TID for 6 days)
Drug: SYNB1020
SYNB1020 (5 × 10 to the 11th CFU, TID)

Placebo Comparator: Placebo
Placebo (100 mL masking solution, TID for 6 days)
Other: Placebo
Placebo 100 mL masking solution

Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [ Time Frame: 80 days from study entry ]
    Will be measured by assessing nature and frequency of AEs

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03447730

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United States, California
Southern California Research Center
Coronado, California, United States, 92118
Inland Empire Liver Foundation
Rialto, California, United States, 92377
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02241
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Texas Liver Institute
San Antonio, Texas, United States, 78006
United States, Virginia
McGuire VA Medical Center
Richmond, Virginia, United States, 23249
Sponsors and Collaborators
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Responsible Party: Synlogic Identifier: NCT03447730    
Other Study ID Numbers: SYNB1020-CP-002
First Posted: February 27, 2018    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases