CompletedNCT00619736Updated Jan 30, 2009

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

A Phase 1 interventional study of NSA-789 and Placebo in Healthy, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer. Completed. Open to male participants aged 20 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-01-30.

Sponsored by Wyeth is now a wholly owned subsidiary of Pfizer · Phase 1 and Interventional

Phase: Phase 1
Study type: Interventional
Enrollment: 56
Allocation: Randomized
Ages: 20 Years to 45 Years
Sex: Male

Study 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.

Conditions studied

Healthy

Keywords

Healthy

In context

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer is the lead sponsor of 472 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years to 45 Years
Sexes eligible: Male
Accepts healthy volunteers: Yes

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

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 design

Phase: Phase 1
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double
Enrollment: 56 participants (actual)

Study arms

Experimental
NSA-789
Drug: NSA-789
Placebo comparator
Placebo
Other: Placebo

Interventions

DrugNSA-789
OtherPlacebo

What researchers measure

Primary outcomes

Safety and Tolerability
Time frame: 3 months

Secondary outcomes

Pharmacokinetics
Time frame: 3 months

Study locations

No study locations are listed for this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 30, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00619736
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
First posted: Feb 21, 2008
Start date: Mar 2008
Primary completion: Sep 2008
Completion: Sep 2008
Last update: Jan 30, 2009

Study contacts

Medical Monitor

study director · Wyeth is now a wholly owned subsidiary of Pfizer

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2009. You cannot join it, but the record below documents what was studied.

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Discussion

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