Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01289080 · ClinicalTrials.gov registry record · Phase 1
Trial Evaluating OPC-34712 in Subjects With Normal Renal Function and Renally Impaired Subjects
A Phase 1 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT01289080: Completed Phase 1 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT01289080 is a Phase 1 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 19 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01289080, a Phase 1 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
This trial is an open-label, multi-center, parallel-arm, single-dose trial in 2 groups: 1 group of subjects with normal renal function and 1 group of severely renally impaired subjects.
Primary Outcome
Blood samples were collected on Day 1 at Predose (within 15 minutes of dosing) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16, 24, 36, 48, 72, 96, 120, 144, and 168 hours Postdose or at Early Termination (ET). Unbound fraction of drug in plasma was calculated as 100% - mean percent of brexpiprazole bound to plasma protein for each participant.
Interventions
- DRUG OPC-34712
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2011-01 |
| Est. Completion | 2012-01 |
| Phase | Phase 1 |
What the finished NCT01289080 record still lists
NCT01289080 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 1 intervention - of which OPC-34712 is the first listed.
NCT01289080 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01289080 about?
NCT01289080 is a clinical study titled "Trial Evaluating OPC-34712 in Subjects With Normal Renal Function and Renally Impaired Subjects". This trial is an open-label, multi-center, parallel-arm, single-dose trial in 2 groups: 1 group of subjects with normal renal function and 1 group of severely renally impaired subjects.
What is the current status of trial NCT01289080?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2011-01. Estimated completion is 2012-01.
What interventions are being tested in trial NCT01289080?
The interventions under investigation include: OPC-34712 (DRUG).
Who is sponsoring clinical trial NCT01289080?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01289080's enrollment target sits among peer trials
19 1716th of 2000 higher than 281 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
- NCT03207464 · 19 participants · Phase 1
Molecular Imaging of NET Using [C-11]MRB-PET in MS
- NCT04318717 · 19 participants · Phase 2
Pembrolizumab and Hypofractionated Radiation Therapy for the Treatment of Mucosal Melanoma
- NCT05103904 · 19 participants · Phase 2
Lenvatinib for the Treatment of Recurrent Hepatocellular Carcinoma After Liver Transplant
- NCT05607407 · 19 participants · Phase 2
Methimazole in Patients With Progressive Glioblastoma
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia