NCT03846843

OCR002-SP103 - Oral Immediate Release Study

An Open-Label, Two-Part, Phase 1/2a, Crossover Study to Determine the Absolute Bioavailability and Pharmacokinetics of Oral Immediate-Release Doses of OCR-002 in Subjects With Varying Degrees of Cirrhosis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Ocera Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label Phase 1, 2-part, crossover study in approximately 33 adult subjects (12 subjects in Part 1 and 21 subjects in Part 2), with varying degrees of cirrhosis with analysis of pharmacokinetic (PK) data after Part 1 to guide dose regimen selection and PK sampling time points for OCR-002 in Part 2.

Detailed description

Part 1: Dosing Periods 1, 2, 3, and 4: Single-dose, partially randomized, 4-period crossover study to evaluate 5 g OCR-002 oral solution administered under fed conditions, fasting conditions, or under fasting conditions following discontinuation of lactulose in 12 subjects with cirrhosis (Child-Pugh class A and C). The purpose is to determine the pharmacokinetics of phenylacetic acid (PAA) and phenylacetylglutamine (PAGN) following a single 5 g dose of OCR-002 oral solution administered under fed conditions, fasting conditions, or under fasting conditions following discontinuation of lactulose as compared to a single 5 g intravenous dose of OCR-002 under fasting conditions in subjects with cirrhosis (Child-Pugh class A and C). Analysis of pharmacokinetic data will be conducted after completion of Part 1 in order to determine the dose regimen of OCR-002 oral tablets to use in Part 2 of the study. Part 2: Dosing Periods 1, 2 and 3: Multiple-dose, randomized, 3-period crossover study to evaluate OCR-002 oral tablets in subjects with cirrhosis (Child-Pugh class B). The purpose is to characterize the PK and pharmacodynamic (PD) of OCR-002 tablets after TID administration for 5 days in subjects with cirrhosis (Child-Pugh class B).

Conditions

• Cirrhosis

Interventions

Type	Name	Description
DRUG	OCR-002 IR Oral Tablet	OCR-002 3 gram immediate release (IR) tablet for oral administration
DRUG	OCR-002 Oral Solution	OCR-002 5 gram solution for oral administration
DRUG	OCR-002 IV Solution	OCR-002 5 gram solution for intravenous (IV ) administration

Timeline

• Start date: 2016-08-15
• Primary completion: 2017-11-30
• Completion: 2017-12-31
• First posted: 2019-02-20
• Last updated: 2021-09-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study