CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 54 enrolled
Drug / intervention
NW-3509adrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01955564
NCT01955564Phase 1Completed
CompareCT.gov

A Phase I, Prospective, Randomized, Double-blind, Placebo-controlled, Sequential-cohort, Escalating, Single-dose Study Designed to Determine the Maximum Tolerated Oral Dose of NW-3509A in Healthy, Male Volunteers.

Newron Pharmaceuticals SPA·interventional·Posted Oct 7, 2013·Updated Jun 20, 2017

In Brief

A Phase 1 clinical trial evaluating NW-3509a for Schizophrenia. Completed, enrolled 54 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 7, 2013
Enrollment StartJun 1, 2013
Primary CompletionSep 1, 2014
Study CompletionFeb 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 12.7 years ago

Interventions

NW-3509adrug

single dose