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Completed

NCT Number: NCT00563810

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

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

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Key information

Conditions

Healthy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MYO-029

Drug

Primary outcomes

  1. To assess safety and tolerability.

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2004
Study completion
2006
First posted
Nov 26, 2007
Registry last updated
Nov 26, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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