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.
Overview
- Phase
- Phase 1
- Intervention
- NW-3509a
- Conditions
- Schizophrenia
- Sponsor
- Newron Pharmaceuticals SPA
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- Physical Examination Shift Table
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Detailed Description
Doses from 1 to 30 mg were tested
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 ≤
- •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.
Exclusion Criteria
- •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;
Arms & Interventions
Cohort 1
NW-3509a - 1mg or placebo
Intervention: NW-3509a
Cohort 2
NW-3509a 2mg or placebo
Intervention: NW-3509a
Cohort 3
NW-3509a 5mg or placebo
Intervention: NW-3509a
Cohort 4
NW-3509a 10 mg or placebo
Intervention: NW-3509a
Cohort 5
NW-3509a 20 mg or placebo
Intervention: NW-3509a
Cohort 6
NW-3509a 30 mg or placebo
Intervention: NW-3509a
Outcomes
Primary Outcomes
Physical Examination Shift Table
Time Frame: Day -1(pre-dose) through Day 8 (Discharge)
Physical examinations were carried out on the following: Lymph nodes, mouth, neck, nervous system, nose, skin and throat.
Secondary Outcomes
- 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)