OCR002-SP103 - Oral Immediate Release Study

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.

Timeline

Start

2016-08-15

Primary completion

2017-11-30

Completion

2017-12-31

Drugs

Indications