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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 is a Phase 1 study that has completed, run by Naurex, Inc, an affiliate of Allergan. The registered enrollment target is 100 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01856556
The ClinicalTrials.gov registry entry for NCT01856556 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Naurex, Inc, an affiliate of Allergan, which has 18 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01856556 reports 0 study locations.
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.
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