A Study of CRV431 Dosed Once Daily in NASH Induced F2 and F3 Subjects
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Fibrosis, Liver
- NAFLD - Nonalcoholic Fatty Liver Disease
- NASH - Nonalcoholic Steatohepatitis
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Randomized, multi-center, single-blindMasking: Single (Participant)Masking Description: placebo-controlledPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
Description
This is a randomized, single-blind, placebo-controlled, once daily (QD) dose study of CRV431 in presumed NASH F2/F3 subjects. Study will evaluate the safety and tolerability of a once daily 75mg dose of CRV431 compared to placebo over 28 days of dosing. Pharmacokinetic parameters of CRV431 and its m...
This is a randomized, single-blind, placebo-controlled, once daily (QD) dose study of CRV431 in presumed NASH F2/F3 subjects. Study will evaluate the safety and tolerability of a once daily 75mg dose of CRV431 compared to placebo over 28 days of dosing. Pharmacokinetic parameters of CRV431 and its major metabolites and fraction unbound will also be evaluated. Non-invasive antifibrotic bio-markers will be collected and quantified from presumed NASH F2/F3 subjects dosed with 75mg CRV431 or placebo.
Tracking Information
- NCT #
- NCT04480710
- Collaborators
- Not Provided
- Investigators
- Study Director: Carlos Canizares, R.Ph. Hepion Pharmaceuticals, Inc.
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