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

Phase 1CompletedNCT00619736

Wyeth is now a wholly owned subsidiary of Pfizer56 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

NSA-789DRUG

PlaceboOTHER

Eligibility

Sex: MALEMin age: 20 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Safety and Tolerability

Time frame: 3 months

Secondary Outcomes

Pharmacokinetics

Time frame: 3 months

Data from ClinicalTrials.gov

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