Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01955564 · ClinicalTrials.gov registry record · Phase 1
A Phase I- Sequential Cohort Dosing to Determine Maximum Tolerated Dose in Healthy Male Volunteers.
A Phase 1 study, sponsored by Newron Pharmaceuticals SPA.
- Completed
- Registry status
- Phase 1
- Development phase
- 54
- Enrollment target
NCT01955564 is a Phase 1 study that has completed, run by Newron Pharmaceuticals SPA. The registered enrollment target is 54 participants.
The verdict
NCT01955564, a Phase 1 study, has completed, sponsored by Newron Pharmaceuticals SPA.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 54 participants
- Enrollment target
Study Summary
This is a prospective, 8-day, randomized, double-blind, placebo-controlled, sequential-cohort study designed to evaluate the safety, tolerability, and MTD of single escalating oral doses of NW-3509A in healthy male volunteers. Six independent cohorts of 12 volunteers each will participate in this study, with the first 9 volunteers in each cohort to qualify being randomized to receive study medication and the remaining 3 to be used as backups/ alternates. In each cohort, 6 subjects will be randomly assigned to receive NW-3509A and 3 subjects will receive placebo.
Interventions
- DRUG NW-3509a
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2013-06 |
| Est. Completion | 2015-02 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01955564
The ClinicalTrials.gov registry entry for NCT01955564 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Newron Pharmaceuticals SPA, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which NW-3509a is the first listed.
NCT01955564 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01955564 about?
NCT01955564 is a clinical study titled "A Phase I- Sequential Cohort Dosing to Determine Maximum Tolerated Dose in Healthy Male Volunteers.". This is a prospective, 8-day, randomized, double-blind, placebo-controlled, sequential-cohort study designed to evaluate the safety, tolerability, and MTD of single escalating oral doses of NW-3509A in healthy male volunteers. Six independent cohorts of 12 volunteers each will participate in this st...
What is the current status of trial NCT01955564?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2013-06. Estimated completion is 2015-02.
What interventions are being tested in trial NCT01955564?
The interventions under investigation include: NW-3509a (DRUG).
Who is sponsoring clinical trial NCT01955564?
This trial is sponsored by Newron Pharmaceuticals SPA, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.