Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study, sponsored by Ocera Therapeutics.
NCT03846843 is a Phase 1 study that has completed, run by Ocera Therapeutics. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Maximum concentration (Cmax) of PAA and PAGN following a single 5 g dose of OCR-002 oral solution under fed or fasting conditions as compared to a single 5 g IV dose of OCR-002 under fasting conditions in participants with cirrhosis (Child-Pugh Classes A and C). Plasma concentrations of PAA, PAGN and ornithine will be analyzed by non-compartmental PK methods.
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 |
What the finished NCT03846843 record still lists
NCT03846843 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 3 interventions - of which OCR-002 IR Oral Tablet is the first listed.
NCT03846843 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03846843's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00977977 · 30 participants · Phase 2
Rituximab Plus Cyclosporine in Idiopathic Membranous Nephropathy
- NCT01459107 · 30 participants · Phase 2
Human Upper Extremity Allotransplantation
- NCT01666080 · 30 participants · NA
Second or Greater Allogeneic Hematopoietic Stem Cell Transplant Using Reduced Intensity Conditioning (RIC)
- NCT01720836 · 30 participants · Phase 1
Study of the Immune Response of MUC1 (Mucin1) Peptide Vaccine for Non-small Cell Lung Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI