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
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.
Investigators
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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