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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2006-04-30

Brief Summary

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

Detailed Description

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Conditions

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Healthy

Keywords

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Adult Aged

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Interventions

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MYO-029

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Other Identifiers

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3147K1-103

Identifier Type: -

Identifier Source: org_study_id