Study Evaluating the Safety, Tolerability and Pharmacokinetics of NSA-789 in Healthy Japanese Male Subjects

Wyeth

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: NSA-789

Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00619736

3230A1-1001

Details and patient eligibility

About

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.

Enrollment

56 patients

Sex

Male

Ages

20 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.