Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of MYO-029
November 23, 2007 updated by: Wyeth is now a wholly owned subsidiary of Pfizer
An Ascending Multiple Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of MYO-029 Administered Intravenously as a 30-Minute Infusion to Healthy Subjects
This is a multiple dose study assessing the safety, tolerability, pharmacokinetics and pharmacodynamics of an investigational new drug.
Study Overview
Study Type
Interventional
Enrollment
72
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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To assess safety and tolerability.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2004
Study Completion (Actual)
April 1, 2006
Study Registration Dates
First Submitted
November 21, 2007
First Submitted That Met QC Criteria
November 23, 2007
First Posted (Estimate)
November 26, 2007
Study Record Updates
Last Update Posted (Estimate)
November 26, 2007
Last Update Submitted That Met QC Criteria
November 23, 2007
Last Verified
November 1, 2007
More Information
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.