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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
47
1 x 75mg softgel capsule
1 x placebo softgel capsule
3 x 75mg softgel capsule
Conquest Clinical Research
Orange, California, United States
Alliance Clinical Research
Poway, California, United States
La Salud Research, Inc.
Miami, Florida, United States
Number of Safety and Tolerability Events of CRV431 Versus Placebo.
Number of adverse events, serious adverse events, and clinical laboratory abnormalities.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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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3 x placebo softgel capsule
Progressive Medical Research
Port Orange, Florida, United States
Covenant Research, LLC.
Sarasota, Florida, United States
Gastrointestinal Specialists of Georgia
Marietta, Georgia, United States
Aventiv Research Inc.
Columbus, Ohio, United States
Quality Research Inc.
San Antonio, Texas, United States
Pinnacle Research Group
San Antonio, Texas, United States
FDI Clinical Research
San Juan, Puerto Rico