Healthy
Conditions
Keywords
Healthy
Brief summary
This study will provide an initial assessment of the safety, tolerability and pharmacokinetics (PK) of NSA-789 after administration of ascending single oral doses to healthy Japanese male subjects. This is a randomized, double-blind, placebo-controlled, inpatient, sequential-group study conducted under fasting conditions at a single investigational site. Each subject will participate in only 1 dose group and will receive only 1 dose of test article.
Interventions
DRUGNSA-789
OTHERPlacebo
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE
Eligibility
Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Men aged 20 to 45 years inclusive at screening. * Healthy as determined by the investigator on the basis of screening evaluations.
Exclusion criteria
* Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease. * Use of any investigational drug within 90 days before study day 1 or prescription drug within 30 days before study day 1 * Any clinically important deviation from normal limits in physical examination, vital signs, 12-lead electrocardiograms (ECGs), or clinical laboratory test results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and Tolerability | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics | 3 months |
Outcome results
None listed