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

January 28, 2009 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

Ascending Single Dose Study of the Safety, Tolerability and Pharmacokinetics of NSA-789 Administered Orally to Healthy Japanese Male Subjects

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo
Experimental: NSA-789
Drug: NSA-789

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and Tolerability
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

February 8, 2008

First Submitted That Met QC Criteria

February 8, 2008

First Posted (Estimate)

February 21, 2008

Study Record Updates

Last Update Posted (Estimate)

January 30, 2009

Last Update Submitted That Met QC Criteria

January 28, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 3230A1-1001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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