The purpose of this study is to test the safety of BMN 255 and to learn about the effect BMN 255 has on you and your hyperoxaluria associated with NAFLD, and compare these effects with a placebo. The primary safety objective of the study is to assess the safety and tolerability of daily oral doses of BMN 255 in adult participants with NAFLD and hyperoxaluria. The primary efficacy objective of the study is to assess 24-hour urine oxalate levels (24-hour urine collection corrected for BSA) following daily oral doses of BMN 255 in adult participants with NAFLD and hyperoxaluria.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
University of Alabama - Department of Urology
Birmingham, Alabama, United States
ProSciento, Inc.
Chula Vista, California, United States
ProSciento, Inc.
Chula Vista Isles, Florida, United States
Georgia Clinical Research, LLC
Lawrenceville, Georgia, United States
The primary safety endpoint is the incidence of adverse events in adult participants with NAFLD and hyperoxaluria
\- Including but not limited to acute liver or kidney injury
Time frame: Treatment Periods 1 & 2 through a 15 day follow-up after period 2. Each treatment period is 7 days separated by a 7-9 day washout period.
To characterize the daily oral dose plasma pharmacokinetics of BMN 255 in adult participants with NAFLD and hyperoxaluria.
Area under the plasma concentration-time curve (AUC)
Time frame: Day 1, Day 7 of treatment periods 1 & 2, each treatment period is 7 days separated by a 7-9 day washout period and Day 15
To characterize the daily oral dose plasma pharmacokinetics of BMN 255 in adult participants with NAFLD and hyperoxaluria.
Maximum observed concentration (Cmax)
Time frame: Day 1, Day 7 of treatment periods 1 & 2, each treatment period is 7 days separated by a 7-9 day washout period and Day 15
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Medpace Clinical Pharmacology Unit
Cincinnati, Ohio, United States
Centricity Research
Columbus, Ohio, United States
Prolato Clinical Research Center
Houston, Texas, United States