Study Evaluating MOA-728 Administered in Healthy Men

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00427258
First received: January 25, 2007
Last updated: July 22, 2011
Last verified: July 2011

January 25, 2007
July 22, 2011
January 2010
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Distribution of drug using radioactive study drug.
Same as current
Complete list of historical versions of study NCT00427258 on ClinicalTrials.gov Archive Site
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Study Evaluating MOA-728 Administered in Healthy Men
An Open-Label, Single-Dose Study of the Mass Balance and Metabolic Disposition of Orally Administered [14C]MOA-728 in Healthy Men

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

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
Drug: MOA-728
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
6
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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.
Male
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
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NCT00427258
3200A3-1106
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Jeff Cohn, Salix Pharmaceuticals
Salix Pharmaceuticals
Not Provided
Study Director: Jeff Cohn Salix Pharmaceuticals
Salix Pharmaceuticals
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP