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This is a randomized, single-blind, placebo-controlled, once daily (QD) dose study of CRV431 in presumed NASH F2/F3 subjects.
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 and 225mg 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRV431 75mg | Experimental | CRV431, softgel capsule, 75mg, QD, 28 days, fasted conditions |
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| Placebo, 75mg | Placebo Comparator | Placebo, softgel capsule, QD, 28 days, fasted conditions |
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| CRV431 225mg | Experimental | CRV431, softgel capsule, 225mg, QD, 28 days, fasted conditions |
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| Placebo, 225mg | Placebo Comparator | CRV431, 3 softgel capsules, 225mg, QD, 28 days, fasted conditions |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRV431 75mg | Drug | 1 x 75mg softgel capsule |
| |
| Placebo (1 softgel) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Safety and Tolerability Events of CRV431 Versus Placebo. | Number of adverse events, serious adverse events, and clinical laboratory abnormalities. | Time from informed consent to study day 42. |
| Tmax, of Once Daily (QD) 75mg and 225mg mg Doses of CRV431 is Presumed Non-alcoholic Steatohepatitis F2/F3 Fibrosis Subjects. | The Tmax value is defined as time to reach maximum whole blood concentration. Each value is a median for the cohort along with the standard deviation presented in hours for Day 1 and Day 28. | Day 1 and Day 28 |
| Cmax, of Once Daily (QD) 75mg and 22mg mg Doses of CRV431 is Presumed Non-alcoholic Steatohepatitis F2/F3 Fibrosis Subjects. | The Cmax value is defined as the maximum whole blood concentration presented as ng/mL. Each value is a geometric mean for the cohort along with the standard deviation for Day 1 and Day 28. | Day 1 and Day 28 |
| AUC 0-last, of Once Daily (QD) 75mg and 225mg mg Doses of CRV431 in Presumed Non-alcoholic Steatohepatitis F2/F3 Fibrosis Subjects. | The AUC 0-last value is defined as the area under the whole blood concentration time curve from time 0 to the time of the last measurable concentration. Each value is a geometric mean for the cohort along with the standard deviation for Day 1 and Day 28. | Timepoints for data collection include 0, 2.0 hours, 4.0 hours, 8 hours on both Day 1 and Day 28. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlos Canizares, R.Ph. | Hepion Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Conquest Clinical Research | Orange | California | 92866 | United States | ||
| Alliance Clinical Research |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo, 75mg | Placebo, softgel capsule, QD, 28 days, fasted conditions Placebo (1 softgel): 1 x placebo softgel capsule |
| FG001 | CRV431 75mg | CRV431, softgel capsule, 75mg, QD, 28 days, fasted conditions CRV431 75mg: 1 x 75mg softgel capsule |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 1, 2021 |
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Randomized, multi-center, single-blind
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placebo-controlled
| Drug |
1 x placebo softgel capsule |
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| CRV431 225mg | Drug | 3 x 75mg softgel capsule |
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| Placebo (3 softgels) | Drug | 3 x placebo softgel capsule |
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| Poway |
| California |
| 92064 |
| United States |
| La Salud Research, Inc. | Miami | Florida | 33155 | United States |
| Progressive Medical Research | Port Orange | Florida | 32127 | United States |
| Covenant Research, LLC. | Sarasota | Florida | 34249 | United States |
| Gastrointestinal Specialists of Georgia | Marietta | Georgia | 30060 | United States |
| Aventiv Research Inc. | Columbus | Ohio | 43213 | United States |
| Quality Research Inc. | San Antonio | Texas | 78209 | United States |
| Pinnacle Research Group | San Antonio | Texas | 78229 | United States |
| FDI Clinical Research | San Juan | 00927 | Puerto Rico |
| FG002 | Placebo, 225mg | CRV431, 3 softgel capsules, 225mg, QD, 28 days, fasted conditions Placebo (3 softgels): 3 x placebo softgel capsule |
| FG003 | CRV431 225mg | CRV431, softgel capsule, 225mg, QD, 28 days, fasted conditions CRV431 225mg: 3 x 75mg softgel capsule |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | CRV431 75mg | CRV431, softgel capsule, 75mg, QD, 28 days, fasted conditions CRV431 75mg: 1 x 75mg softgel capsule |
| BG001 | Placebo, 75mg | Placebo, softgel capsule, QD, 28 days, fasted conditions Placebo (1 softgel): 1 x placebo softgel capsule |
| BG002 | CRV431 225mg | CRV431, softgel capsule, 225mg, QD, 28 days, fasted conditions CRV431 225mg: 3 x 75mg softgel capsule |
| BG003 | Placebo, 225mg | CRV431, 3 softgel capsules, 225mg, QD, 28 days, fasted conditions Placebo (3 softgels): 3 x placebo softgel capsule |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| BMI | Mean | Standard Deviation | kg/m^2 |
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| ALT | Mean | Standard Deviation | IU/mL |
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| AST | Mean | Standard Deviation | IU/mL |
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| Pro-C3 | Missing baseline value | Mean | Standard Deviation | ng/mL |
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| ELF Score | Calculated from three markers of fibrosis, hyaluronic acid, tissue inhibitor of matrix metalloproteinase-1 and aminoterminal propeptide of procollagen type III. Lower Risk: < 9.8 Mid Risk: 9.8 - 11.29 Higher Risk: >11.30 The ELF Score is a unitless numerical value. *Harrison SA, Wong VW, Okanoue T, et al. Selonsertib for patients with bridging fibrosis or compensated cirrohsis due to NASH: Results from randomized phase III STELLAR trials. J Hepatol. 2020 Jul;73 (1) : 26-39. | Mean | Standard Deviation | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Safety and Tolerability Events of CRV431 Versus Placebo. | Number of adverse events, serious adverse events, and clinical laboratory abnormalities. | Safety population. | Posted | Number | Number of treatment emergent AE | Time from informed consent to study day 42. |
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| Primary | Tmax, of Once Daily (QD) 75mg and 225mg mg Doses of CRV431 is Presumed Non-alcoholic Steatohepatitis F2/F3 Fibrosis Subjects. | The Tmax value is defined as time to reach maximum whole blood concentration. Each value is a median for the cohort along with the standard deviation presented in hours for Day 1 and Day 28. | Posted | Median | Standard Deviation | hours | Day 1 and Day 28 |
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| Primary | Cmax, of Once Daily (QD) 75mg and 22mg mg Doses of CRV431 is Presumed Non-alcoholic Steatohepatitis F2/F3 Fibrosis Subjects. | The Cmax value is defined as the maximum whole blood concentration presented as ng/mL. Each value is a geometric mean for the cohort along with the standard deviation for Day 1 and Day 28. | Posted | Geometric Mean | Standard Deviation | ng/mL | Day 1 and Day 28 |
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| Primary | AUC 0-last, of Once Daily (QD) 75mg and 225mg mg Doses of CRV431 in Presumed Non-alcoholic Steatohepatitis F2/F3 Fibrosis Subjects. | The AUC 0-last value is defined as the area under the whole blood concentration time curve from time 0 to the time of the last measurable concentration. Each value is a geometric mean for the cohort along with the standard deviation for Day 1 and Day 28. | Posted | Geometric Mean | Standard Deviation | h*ng/mL | Timepoints for data collection include 0, 2.0 hours, 4.0 hours, 8 hours on both Day 1 and Day 28. |
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Adverse events were collected from time of informed consent to day 42 of the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CRV431 75mg | CRV431, softgel capsule, 75mg, QD, 28 days, fasted conditions CRV431 75mg: 1 x 75mg softgel capsule | 0 | 15 | 0 | 15 | 5 | 15 |
| EG001 | Placebo, 75mg | Placebo, softgel capsule, QD, 28 days, fasted conditions Placebo (1 softgel): 1 x placebo softgel capsule | 0 | 6 | 0 | 6 | 3 | 6 |
| EG002 | CRV431 225mg | CRV431, softgel capsule, 225mg, QD, 28 days, fasted conditions CRV431 225mg: 3 x 75mg softgel capsule | 0 | 17 | 0 | 17 | 10 | 17 |
| EG003 | Placebo, 225mg | CRV431, 3 softgel capsules, 225mg, QD, 28 days, fasted conditions Placebo (3 softgels): 3 x placebo softgel capsule | 0 | 9 | 0 | 9 | 3 | 9 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 23.0 | Systematic Assessment | Administration site condition |
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| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
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| Abdominal Distension | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Gastrointestinal sounds abnormal | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Gastroesophageal reflux disease | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Paraesthesia oral | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Pain | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Seasonal Allergy | Immune system disorders | MedDRA 23.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Vaccination complication | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA 23.0 | Systematic Assessment |
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| Body temperature decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
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| SARS-CoV2 test positive | Investigations | MedDRA 23.0 | Systematic Assessment |
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| Weight increased | Investigations | MedDRA 23.0 | Systematic Assessment |
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| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Cold sweat | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Operations | Hepion Pharmaceuticals Inc | 732-902-4016 | jgreytok@hepionpharma.com |
| Jun 6, 2022 |
| Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000654430 | CRV-431 |
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| Relationship-unrelated |
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| Relationship-possibly related |
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| Relationship-probably related |
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| Severity-Mild Grade 1 |
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| Severity-Moderate Grade2 |
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| Severity-Severe Grade 3 |
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| Severity-Grade 4 |
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| Number of Treatment Emergent Adverse Events leading to study withdrawl |
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| Participants |
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