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Study of the Safety and Tolerability of AXA1665 in Subjects With Mild and Moderate Hepatic Insufficiency

NCT04147936 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-09-18

No results posted yet for this study

Summary

This is a randomized, single blind study to determine whether AXA1665, a composition of naturally occuring amino acids, is well tolerated in subjects with mild and moderate hepatic insufficiency. Study will also examine how the food product may influence the biology in muscle which will be assessed using magnetic resonance imaging (MRI) and other functional assessments such as strength, balance and cognition as part of a comprehensive physical/neurological exam. Changes in blood biomarkers of inflammation will also be assessed.

Conditions

  • Hepatic Insufficiency

Interventions

DIETARY_SUPPLEMENT

AXA1665

Dietary supplement: AXA1665

DIETARY_SUPPLEMENT

Placebo

Placebo

Sponsors & Collaborators

  • Axcella Health, Inc

    lead INDUSTRY

Principal Investigators

  • Arun J Sanyal, MD · Virginia Commonwealth University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-30
Primary Completion
2020-05-20
Completion
2020-06-24

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04147936 on ClinicalTrials.gov