Trials / Completed
CompletedNCT03432260
A Research Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of DUR-928 in Patients With Alcoholic Hepatitis
An Open- Label, Dose Escalation Study to Assess the Safety, Pharmacokinetics and Pharmacodynamic Signals of DUR-928 in Patients With Alcoholic Hepatitis
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 19 (actual)
- Sponsor
- Durect · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2018-04-18
- Primary completion
- 2019-09-09
- Completion
- 2019-09-09
- First posted
- 2018-02-14
- Last updated
- 2024-09-24
- Results posted
- 2022-12-14
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03432260. Inclusion in this directory is not an endorsement.