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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00563810
First received: November 21, 2007
Last updated: November 23, 2007
Last verified: November 2007
  Purpose

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


Condition Intervention Phase
Healthy
Drug: MYO-029
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Health Services Research
Official Title: An Ascending Multiple Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of MYO-029 Administered Intravenously as a 30-Minute Infusion to Healthy Subjects

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • To assess safety and tolerability.

Estimated Enrollment: 72
Study Start Date: October 2004
Study Completion Date: April 2006
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00563810

Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00563810     History of Changes
Other Study ID Numbers: 3147K1-103
Study First Received: November 21, 2007
Last Updated: November 23, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Adult
Aged

ClinicalTrials.gov processed this record on April 16, 2014