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

Wyeth

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: MYO-029

Study type: Interventional

Funder types: Industry

Identifiers

NCT00563810

3147K1-103

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind