AMBITION
AMBITION: A Phase 2A, Multiple-Center, Single-Blind, Placebo-Controlled Study To Evaluate The Safety and Tolerability of CRV431 Dosed Once Daily in NASH Induced F2 and F3 Subjects
Sponsor study identifier
interventional
47
2 countries
10
Study Start
June 23, 2020
Actual (reported)Primary Completion
June 29, 2021
Actual (reported)Study Completion
October 30, 2021
Actual (reported)This is a randomized, single-blind, placebo-controlled, once daily (QD) dose study of CRV431 in presumed NASH F2/F3 subjects.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 30, 2021
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 23, 2020
Actual (reported)July 9, 2020
Actual (reported)July 21, 2020
Actual (reported)June 29, 2021
Actual (reported)October 30, 2021
Actual (reported)July 15, 2022
Actual (reported)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
CRV431, softgel capsule, 75mg, QD, 28 days, fasted conditions
Placebo, softgel capsule, QD, 28 days, fasted conditions
CRV431, softgel capsule, 225mg, QD, 28 days, fasted conditions
Conquest Clinical Research
Orange, California, 92866, United States
Alliance Clinical Research
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
Carlos Canizares, R.Ph.
Hepion Pharmaceuticals, Inc.
47 participants (actual enrollment reported by the registry).
First Submitted
July 9, 2020
First Posted
July 21, 2020
Study Start
June 23, 2020
Actual (reported)Study Evaluating the Safety, Efficacy and Tolerability of BIO89-100 in Subjects With Biopsy-confirmed Nonalcoholic Steatohepatitis (NASH)
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.
CRV431, 3 softgel capsules, 225mg, QD, 28 days, fasted conditions
3 x 75mg softgel capsule
Contact the study team to confirm eligibility.
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
Primary Completion
June 29, 2021
Actual (reported)Study Completion
October 30, 2021
Actual (reported)Last Updated
July 15, 2022
Results First Posted
July 15, 2022
Record last verified: 2022-06
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: