Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NSA-789 Administered Orally to Healthy Subjects
NSA-789
+ placebo
Summary
Study start date: March 1, 2008
Actual date on which the first participant was enrolled.This is the first time that NSA-789, a new compound being developed for schizophrenia, will be given to humans. Each healthy subject will receive a single dose, except for 8 subjects who will receive 2 doses-- one dose under fasting conditions and one dose after eating food.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.64 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 50 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Inclusion: * Healthy men and women between 18 and 50 years old. * Women must be of non-child-bearing potential (not able to have children). * Must be of normal body weight.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives