Ocera Announces Complete Plasma Data From Pilot Phase 1 Study for Orally-Available OCR-002 in Development for the Prevention of Chronic Hepatic Encephalopathy
The mean maximum concentration (Cmax) of plasma PAA from the three pilot OCR-002 extended-release formulations ranged from approximately 50 to 90µg/mL occurring at various time points over 4 to 9 hours after dosing. For comparison, RAVICTI® produced a mean plasma PAA Cmax of approximately 10µg/mL at 4 to 6 hours after dosing. The plasma PAA data after a single oral dose of 6mL RAVICTI® are consistent with published data in healthy subjects.3,4 In addition, PAA exposure with the extended-release formulations of OCR-002 showed lower inter-subject variability than RAVICTI®.
Plasma profiles of PAGN, the end-product of ammonia scavenging, also demonstrated a similar pattern as the PAA profiles. The mean Cmax of plasma PAGN from the pilot extended-release formulations of OCR-002 ranged from approximately 30 to 45µg/mL occurring at various time points over 4 to 10 hours after dosing. For comparison, RAVICTI® produced a mean plasma PAGN Cmax of about 20 to 25µg/mL at approximately 5 hours. These data are also consistent with the published data in healthy subjects.3,4