NCT00619736

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Mar 2008

Typical duration for phase_1 healthy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 21, 2008

Completed
9 days until next milestone

Study Start

First participant enrolled

March 1, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

January 30, 2009

Status Verified

January 1, 2009

Enrollment Period

6 months

First QC Date

February 8, 2008

Last Update Submit

January 28, 2009

Conditions

Healthy

Keywords

Healthy

Outcome Measures

Primary Outcomes (1)

  • Safety and Tolerability

    3 months

Secondary Outcomes (1)

  • Pharmacokinetics

    3 months

Study Arms (2)

NSA-789

EXPERIMENTAL
Drug: NSA-789

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

NSA-789DRUG
NSA-789
PlaceboOTHER
Placebo

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Men aged 20 to 45 years inclusive at screening.
  • Healthy as determined by the investigator on the basis of screening evaluations.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 8, 2008

First Posted

February 21, 2008

Study Start

March 1, 2008

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

January 30, 2009

Record last verified: 2009-01