Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of MYO-029

Phase 1

Completed

• Conditions: Healthy

• Registration Number: NCT00563810
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Study Completion: 2006-04
• Status Verified: 2007-11
• Study First Submitted: 2007-11-21
• Study First Submitted QC: 2007-11-23
• Last Update Submitted: 2007-11-23
• Study First Posted: 2007-11-26
• Last Update Posted: 2007-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Men aged 18 to 45 years inclusive on study day 1.
• Elderly men and women aged 65 to 80 years inclusive on study day 1.
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To assess safety and tolerability.