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NCT03846843 · ClinicalTrials.gov registry record · Phase 1
OCR002-SP103 - Oral Immediate Release Study
A Phase 1 study, sponsored by Ocera Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT03846843 is a Phase 1 study that has completed, run by Ocera Therapeutics. The registered enrollment target is 30 participants.
The verdict
NCT03846843, a Phase 1 study, has completed, sponsored by Ocera Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
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.
Interventions
- DRUG OCR-002 IR Oral Tablet
- DRUG OCR-002 Oral Solution
- DRUG OCR-002 IV Solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2016-08-15 |
| Est. Completion | 2017-12-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03846843
The ClinicalTrials.gov registry entry for NCT03846843 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ocera Therapeutics, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which OCR-002 IR Oral Tablet is the first listed.
NCT03846843 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03846843 about?
NCT03846843 is a clinical study titled "OCR002-SP103 - Oral Immediate Release Study". 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-0...
What is the current status of trial NCT03846843?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2016-08-15. Estimated completion is 2017-12-31.
What interventions are being tested in trial NCT03846843?
The interventions under investigation include: OCR-002 IR Oral Tablet (DRUG), OCR-002 Oral Solution (DRUG), OCR-002 IV Solution (DRUG).
Who is sponsoring clinical trial NCT03846843?
This trial is sponsored by Ocera Therapeutics, which has 9 total clinical trials registered on ClinicalTrials.gov.
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