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This study has been withdrawn prior to enrollment.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
  Purpose

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


Condition Intervention Phase
Healthy
Drug: MOA-728
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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 Salix Pharmaceuticals:

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

Estimated Enrollment: 6
Study Start Date: January 2010
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00427258

Sponsors and Collaborators
Salix Pharmaceuticals
Investigators
Study Director: Jeff Cohn Salix Pharmaceuticals
  More Information

No publications provided

Responsible Party: Jeff Cohn, Salix Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00427258     History of Changes
Other Study ID Numbers: 3200A3-1106
Study First Received: January 25, 2007
Last Updated: July 22, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Salix Pharmaceuticals:
healthy subjects

ClinicalTrials.gov processed this record on July 20, 2014