Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01856556 · ClinicalTrials.gov registry record · Phase 1
Safety and Pharmacokinetics of NRX-1074 in Normal Volunteers
A Phase 1 study, sponsored by Naurex, Inc, an affiliate of Allergan.
- Completed
- Registry status
- Phase 1
- Development phase
- 100
- Enrollment target
NCT01856556: Completed Phase 1 study, sponsored by Naurex, Inc, an affiliate of Allergan.
NCT01856556 is a Phase 1 study that has completed, run by Naurex, Inc, an affiliate of Allergan. The registered enrollment target is 100 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01856556, a Phase 1 study, has completed, sponsored by Naurex, Inc, an affiliate of Allergan.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 100 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the safety and tolerability of a single intravenous (IV) and oral (PO) ascending dose of NRX-1074 as evidenced by the incidence and severity of adverse events (AEs), changes in serum chemistry, hematology, and urinalysis, changes in physical examination findings and subject-reported symptoms. The secondary objectives of this study are to assess the plasma and cerebrospinal fluid (CSF) pharmacokinetics (PK), the oral bioavailability of experimental formulations and the renal elimination through urine concentration of NRX-1074 through 24 hours following dosing.
Interventions
- DRUG Placebo
- DRUG NRX-1074
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2013-05 |
| Est. Completion | 2014-11 |
| Phase | Phase 1 |
What the finished NCT01856556 record still lists
NCT01856556 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01856556 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01856556 about?
NCT01856556 is a clinical study titled "Safety and Pharmacokinetics of NRX-1074 in Normal Volunteers". The primary objective of this study is to evaluate the safety and tolerability of a single intravenous (IV) and oral (PO) ascending dose of NRX-1074 as evidenced by the incidence and severity of adverse events (AEs), changes in serum chemistry, hematology, and urinalysis, changes in physical examina...
What is the current status of trial NCT01856556?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2013-05. Estimated completion is 2014-11.
What interventions are being tested in trial NCT01856556?
The interventions under investigation include: Placebo (DRUG), NRX-1074 (DRUG).
Who is sponsoring clinical trial NCT01856556?
This trial is sponsored by Naurex, Inc, an affiliate of Allergan, which has 18 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01856556's enrollment target sits among peer trials
100 546th of 2000 higher than 1,411 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
- NCT01048281 · 100 participants
Clinical & Pathological Studies of Upper Gastrointestinal Carcinoma
- NCT01161199 · 100 participants
The Use of Leukapheresis to Support HIV Pathogenesis Studies
- NCT01327690 · 100 participants · Early Phase 1
Mental Health in Veterans and Families After Group Therapies
- NCT01730781 · 100 participants
Imaging Cannabinoid Receptors Using Positron Emission Tomography (PET) Scanning
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