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

NCT01955564 | Completed Phase 1 Results DMC

• 1 other identifier: NW-3509A/001/I/2011
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Physical Examination Shift Table

  Physical examinations were carried out on the following: Lymph nodes, mouth, neck, nervous system, nose, skin and throat.

  Day -1(pre-dose) through Day 8 (Discharge)

Secondary Outcomes (2)

• Maximum Plasma Concentration of NW-3509A at Doses Tested

  Baseline up to 32 hours post-dose

• Total Drug Exposure Over Time (AUC0-t) of NW-3509A at Doses Tested

  Baseline up to 32 hours post-dose

Study Arms (6)

Cohort 1

EXPERIMENTAL

NW-3509a - 1mg or placebo

Drug: NW-3509a

Cohort 2

EXPERIMENTAL

NW-3509a 2mg or placebo

Drug: NW-3509a

Cohort 3

EXPERIMENTAL

NW-3509a 5mg or placebo

Drug: NW-3509a

Cohort 4

EXPERIMENTAL

NW-3509a 10 mg or placebo

Drug: NW-3509a

Cohort 5

EXPERIMENTAL

NW-3509a 20 mg or placebo

Drug: NW-3509a

Cohort 6

EXPERIMENTAL

NW-3509a 30 mg or placebo

Drug: NW-3509a

Interventions

NW-3509a DRUG

single dose

Also known as: NW-3509

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 6

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Demographics
• Age - between 18 and 45 years of age, inclusive.
• Sex - males.
• 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:
• They are cooperative, able to take oral medication, willing to complete all aspects of the study, and capable of doing so.
• They will be able to understand the instructions and fully participate.
• They will have provided written informed consent prior to participating in the study.
• The subject is in good health with no history of significant medical disease as determined by the investigator.

You may not qualify if:

• The presence of any of the following will exclude a subject from study enrollment:
• General Medical Status
• 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);
• A disability that may prevent the volunteer from completing all study requirements (e.g., blindness, deafness, severe language difficulty);
• A current diagnosis of active, uncontrolled peptic ulceration within the last year;
• A current diagnosis of acute, severe, or unstable asthmatic condition.
• Cardiovascular
• A current diagnosis of severe or unstable cardiovascular disease;
• A current diagnosis of sick-sinus syndrome or conduction deficits (e.g., sino-atrial block (\<0.22), second or third degree atrio-ventricular block);
• Any history or current evidence of a cardiac illness as determined by the investigator;
• Vital signs (supine) outside the following ranges:
• Systolic blood pressure below 100 or above 139 mmHg;
• Diastolic blood pressure below 50 or above 89 mmHg;
• Radial pulse below 50 or above 90 bpm.
• CNS related

Sponsors & Collaborators

• Newron Pharmaceuticals SPA: lead

Study Sites (1)

Collaborative Neuroscience Network-Clinical Pharmacology Unit

Long Beach, California, 90806, United States

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Ravi Anand
• Organization: Newron Pharmaceuticals S.p.A.

ravi@anand.ch

+39 026103461

Study Officials

• Mark Leibowitz, MD

  Collaborative Neuroscience Network Phase I Unit

  PRINCIPAL INVESTIGATOR

• Ravi Anand, MD

  Newron Pharmaceuticals SPA

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2013
• First Posted: October 7, 2013
• Study Start: June 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: February 1, 2015
• Last Updated: June 20, 2017
• Results First Posted: June 20, 2017

Record last verified: 2017-04

Locations

US (1)