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

Completed · Phase 1

Conditions studied: Schizophrenia

In brief

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.

Key facts

Study ID

NCT01955564

Run by

Newron Pharmaceuticals SPA

People needed

54

Starts

2013-06-01

Expected to finish

2015-02-01

Last updated by the study team

2017-06-20

Who can join

Age: 18 and older, up to 45. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Demographics
• Volunteers will meet the following demographic inclusion criteria:
• 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;
• Any clinically significant ECG abnormality, including a disorder of rate, rhythm, or conduction, or other morphological changes, or a QTcF interval (Fridericia's correction formula) on the ECG >450 msec. The 12-lead ECG will be used for determining the suitability of the subject for inclusion in the study (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
• Any history or current diagnosis of any neurodegenerative illness;
• History or current diagnosis of epilepsy or seizure disorder.
• Psychiatric
• Any past or current psychiatric illness (DSM-IV-TR Axis 1 diagnosis);
• Subjects with current or past suicidal ideation.
• Study-specific criteria
• History of serious adverse reactions or hypersensitivity to any drug;
• Presence or history of allergies requiring acute or chronic treatment (except seasonal allergic rhinitis);
• Alcohol or drug abuser; currently or at any time in the last 5 years;

Where it is running

• Collaborative Neuroscience Network-Clinical Pharmacology Unit — Long Beach, California, United States

Full record on ClinicalTrials.gov

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