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

Durect

Status and phase: Completed; Phase 2

Conditions: Alcoholic Hepatitis

Treatments: Drug: DUR-928 30 mg; Drug: DUR-928 90 mg; Drug: DUR-928 150 mg

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03432260

C928-010

Details and patient eligibility

About

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).

Enrollment: 19 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Able to provide written informed consent (either from patient or patient's legally acceptable representative)

2. Male or female patients 21 years of age or older with BMI ≥ 20 to ≤ 40 kg/m2

3. Patients with alcoholic hepatitis defined as:

   1. History of heavy alcohol abuse: > 40 g/day in females or > 60 g/day in males for a minimum period of 6 months, AND
   2. Consumed alcohol within 12 weeks of entry into the study, AND
   3. Serum bilirubin > 3 mg/dL AND AST > ALT, but less than 300 U/L AND
   4. MELD score between 11-30, inclusive

4. No evidence of active infection as determined by the investigator.

5. Women of child-bearing potential must utilize appropriate birth control throughout the study duration.

6. Male patients must agree to use a medically acceptable method of contraception/birth control throughout the study duration

Exclusion criteria

1. Other or concomitant cause(s) of liver disease as a result of:

   1. Autoimmune liver disease
   2. Wilson disease
   3. Vascular liver disease
   4. Drug induced liver disease

2. Co-infection with human immunodeficiency virus (HIV) or Hepatitis B

3. Any active malignancies other than curatively treated skin cancer (basal cell or squamous cell carcinomas)

4. If female, known pregnancy, or has a positive serum pregnancy test, or lactating/breastfeeding

5. Serum creatinine > 2.5 mg/dL

6. Patients who have had organ transplantation (such as liver, kidney, lung, heart, bone marrow, or stem cell etc.), other than cornea transplant

7. Stage 3 or greater encephalopathy by West Haven criteria

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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19 participants in 6 patient groups

Part A (Moderate AH) DUR-928 30 mg

Experimental group

Description:

Lowest dose of 3 dose escalation arms: 30mg, 90 mg and 150 mg

Treatment:

Drug: DUR-928 30 mg

Part A (Moderate AH) DUR-928 90 mg

Experimental group

Description:

Middle dose of 3 dose escalation arms: 30mg, 90 mg and 150 mg

Treatment:

Drug: DUR-928 90 mg

Part A (Moderate AH) DUR-928 150 mg

Experimental group

Description:

Highest dose of dose escalation arms: 30mg, 90 mg and 150 mg

Treatment:

Drug: DUR-928 150 mg

Part B (Severe AH) DUR-928 30 mg

Experimental group

Description:

Lowest dose of dose escalation arms: 30mg, 90 mg and 150 mg

Treatment:

Drug: DUR-928 30 mg

Part B (Severe AH) DUR-928 90 mg

Experimental group

Description:

Middle dose of dose escalation arms: 30mg, 90 mg and 150 mg

Treatment:

Drug: DUR-928 90 mg

Part B (Severe AH) DUR-928 150 mg

Experimental group

Description:

Highest dose of dose escalation arms: 30mg, 90 mg and 150 mg

Treatment:

Drug: DUR-928 150 mg