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A Phase I- Sequential Cohort Dosing to Determine Maximum Tolerated Dose in Healthy Male Volunteers. | Clinical Trials | Clareo Health

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A Phase I- Sequential Cohort Dosing to Determine Maximum Tolerated Dose in Healthy Male Volunteers.

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.

NCT01955564•Newron Pharmaceuticals SPA

View on ClinicalTrials.gov

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.

Detailed Description

Doses from 1 to 30 mg were tested

Eligibility

Age

18 - 45 years

Sex

MALE

Healthy Volunteers

Yes

Inclusion Criteria

•Demographics
•1. Age - between 18 and 45 years of age, inclusive.
•2. Sex - males.
•3. The subject has a body weight of at least 45 kg and a body mass index of ≤30.
•Procedural
•Volunteers will meet the following procedural criteria:
•4. They are cooperative, able to take oral medication, willing to complete all aspects of the study, and capable of doing so.
•5. They will be able to understand the instructions and fully participate.
•6. They will have provided written informed consent prior to participating in the study.
•7. The subject is in good health with no history of significant medical disease as determined by the investigator.

Exclusion Criteria

•The presence of any of the following will exclude a subject from study enrollment:
•General Medical Status
•1. An advanced, severe, or unstable disease of any type that may interfere with any of the study evaluations, including any medical condition that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical or mental status of the volunteer to a significant degree or put the volunteer at special risk (e.g., liver or kidney disease; malignancy);
•2. A disability that may prevent the volunteer from completing all study requirements (e.g., blindness, deafness, severe language difficulty);
•3. A current diagnosis of active, uncontrolled peptic ulceration within the last year;
•4. A current diagnosis of acute, severe, or unstable asthmatic condition.
•Cardiovascular
•5. A current diagnosis of severe or unstable cardiovascular disease;
•6. A current diagnosis of sick-sinus syndrome or conduction deficits (e.g., sino-atrial block (\<0.22), second or third degree atrio-ventricular block);
•7. Any history or current evidence of a cardiac illness as determined by the investigator;
+37 more criteria

Locations (1)

Collaborative Neuroscience Network-Clinical Pharmacology Unit

Long Beach, California, United States

Key Dates

Start Date

June 1, 2013

Primary Completion Date

September 1, 2014

Completion Date

February 1, 2015

Last Updated

June 20, 2017

Enrollment

ACTUAL participants

Conditions

Schizophrenia

Interventions

NW-3509a

DRUG

Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders

NCT07455929

Psychotic DisordersSchizophrenia Spectrum Disorders

View study

RECRUITING

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

NCT06740383

Schizophrenia Spectrum and Other Psychotic DisordersSchizophrenia+5 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 20, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Phase I- Sequential Cohort Dosing to Determine Maximum Tolerated Dose in Healthy Male Volunteers.

Inclusion Criteria

Exclusion Criteria

Feasibility, Acceptability, and Preliminary Efficacy of Yoga-based Group Intervention for Outpatients With Schizophrenia Spectrum Disorders

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

A Study to Assess the Efficacy and Safety of ML-007C-MA for the Treatment of Inpatient Adults With Schizophrenia

Acceptability, Feasibility and Preliminary Outcomes of the Kiso Mind App for Outpatients With Schizophrenia Spectrum Disorders

Develop a Novel Occupational Training Program for Schizophrenia Patients Based on Virtual Reality Techniques

Brain Stimulation to the Hippocampus in Schizophrenia