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

This study has been completed.

First Received: February 8, 2008 Last Updated: January 28, 2009 History of Changes

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00619736

Purpose

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.

Condition	Intervention	Phase
Healthy	Drug: NSA-789 Other: Placebo	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Parallel Assignment, Safety Study
Official Title:	Ascending Single Dose Study of the Safety, Tolerability and Pharmacokinetics of NSA-789 Administered Orally to Healthy Japanese Male Subjects

Further study details as provided by Wyeth:

Primary Outcome Measures:

Safety and Tolerability [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pharmacokinetics [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment:	56
Study Start Date:	March 2008
Study Completion Date:	September 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
NSA-789: Experimental	Drug: NSA-789
Placebo: Placebo Comparator	Other: Placebo

Eligibility

Ages Eligible for Study:	20 Years to 45 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00619736

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3230A1-1001
Study First Received:	February 8, 2008
Last Updated:	January 28, 2009
ClinicalTrials.gov Identifier:	NCT00619736 History of Changes
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Wyeth:

Healthy

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on May 07, 2009