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Clinical Trials/NCT00563810
NCT00563810
Completed
Phase 1

An Ascending Multiple Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of MYO-029 Administered Intravenously as a 30-Minute Infusion to Healthy Subjects

Wyeth is now a wholly owned subsidiary of Pfizer0 sites72 target enrollmentOctober 2004
ConditionsHealthy
DrugsMYO-029

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Healthy
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Enrollment
72
Primary Endpoint
To assess safety and tolerability.
Status
Completed
Last Updated
18 years ago

Overview

Brief Summary

This is a multiple dose study assessing the safety, tolerability, pharmacokinetics and pharmacodynamics of an investigational new drug.

Registry
clinicaltrials.gov
Start Date
October 2004
End Date
April 2006
Last Updated
18 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer

Eligibility Criteria

Inclusion Criteria

  • Men aged 18 to 45 years inclusive on study day
  • Elderly men and women aged 65 to 80 years inclusive on study day
  • Women must be postmenopausal for \> or = 1 year (with estradiol \< 25 pg/mL and an FSH \> 40 mIU/mL).
  • Healthy as determined by the investigator on the basis of medical history, physical examination, vital signs, clinical laboratory test results, and 12-leave electrocardiogram.
  • Elderly subjects may have stable, nonclinically significant abnormalities on physical examination, and laboratory evaluation.
  • Non-smoker.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

To assess safety and tolerability.

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