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OCR002-SP103 - Oral Immediate Release Study

NCT03846843 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-09-20

No results posted yet for this 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.

Conditions

  • Cirrhosis

Interventions

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

Sponsors & Collaborators

  • Ocera Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Clinical Team Leader · Mallinckrodt

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-15
Primary Completion
2017-11-30
Completion
2017-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03846843 on ClinicalTrials.gov