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A Research Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of DUR-928 in Patients With Alcoholic Hepatitis

NCT03432260 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2024-09-24

Study results available
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Summary

This is a research trial testing DUR-928 (an experimental medication). The purpose of this trial is to assess the dose related safety, Pharmacokinetics, and Pharmacodynamics of DUR 928 in patients with moderate and severe alcoholic hepatitis (AH).

Conditions

  • Alcoholic Hepatitis

Interventions

DRUG

DUR-928 30 mg

Lowest dose of 3 dose escalation arms.

DRUG

DUR-928 90 mg

Middle dose of 3 dose escalation arms.

DRUG

DUR-928 150 mg

Highest dose of 3 dose escalation arms.

Sponsors & Collaborators

  • CTI Clinical Trial and Consulting Services

    collaborator OTHER

  • Durect

    lead INDUSTRY

Principal Investigators

  • Robert Gordon, MD · CTI Clinical Trial and Consulting Services

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-18
Primary Completion
2019-09-09
Completion
2019-09-09
FDA Drug
Yes

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 NCT03432260 on ClinicalTrials.gov