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Study Evaluating MOA-728 Administered in Healthy Men
This study is not yet open for participant recruitment.
Verified by Wyeth, January 2007
Sponsored by: Wyeth
Information provided by: Wyeth
ClinicalTrials.gov Identifier: NCT00427258
  Purpose

Absorption, distribution, metabolism, and excretion (ADME) study with 14C in healthy young men.


Condition Intervention Phase
Healthy
Drug: MOA-728
Phase I

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
Official Title: An Open-Label, Single-Dose Study of the Mass Balance and Metabolic Disposition of Orally Administered [14C]MOA-728 in Healthy Men

Further study details as provided by Wyeth:

Primary Outcome Measures:
  • Distribution of drug using radioactive study drug.

Estimated Enrollment: 6
Study Start Date: January 2007
Estimated Study Completion Date: February 2007
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men aged 18 to 50 years inclusive at screening.
  • Body mass index (BMI) in the range of 18.0 to 30.0 kg/m2 and body weight ≥50 kg. BMI is calculated by taking the subject’s weight, in kilograms, divided by the square of the subject’s height, in meters, at screening: BMI = weight (kg)/[height (m)]2
  • Healthy as determined by the investigator on the basis of screening evaluations.
  • Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00427258

Contacts
Contact: Trial Manager clintrialparticipation@wyeth.com

Sponsors and Collaborators
Wyeth
Investigators
Study Director: Medical Monitor Wyeth
  More Information

Study ID Numbers: 3200A3-1106
Study First Received: January 25, 2007
Last Updated: January 26, 2007
ClinicalTrials.gov Identifier: NCT00427258  
Health Authority: United States: Food and Drug Administration

Keywords provided by Wyeth:
healthy subjects

Study placed in the following topic categories:
Healthy

ClinicalTrials.gov processed this record on January 13, 2009