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Study Evaluating the Safety of MOA-728 Administered Orally to Healthy Subjects

This study has been completed.
Sponsor:
Information provided by:
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00311350
First received: April 3, 2006
Last updated: July 22, 2011
Last verified: July 2011
History of Changes
  Purpose

This is the first multiple-dose experience in humans with MOA-728 in an oral formulation. This study will provide an assessment of the safety, tolerability, and pharmacokinetics (PK) of MOA-728 following administration of ascending multiple oral doses to healthy subjects.


Condition Intervention Phase
Postoperative Complications
Constipation
 Drug: MOA-728
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Masking: Double-Blind
Official Title: Ascending Multiple Dose Study of the Safety, Tolerability, and Pharmacokinetics of MOA-728 Administered Orally to Healthy Subjects

Resource links provided by NLM:

MedlinePlus related topics: Constipation
U.S. FDA Resources

Further study details as provided by Salix Pharmaceuticals:

Primary Outcome Measures:
  • Safety

Estimated Enrollment: 48
Study Start Date: March 2006
Estimated Study Completion Date: August 2006
  Eligibility

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

Inclusion Criteria:

  • Healthy men and women
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00311350

Locations
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19148
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: NCT00311350     History of Changes
Other Study ID Numbers: 3200A3-100
Study First Received: April 3, 2006
Last Updated: July 22, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Salix Pharmaceuticals:
Safety
Health
Pharmacokinetics
ileus

Additional relevant MeSH terms:
Constipation
Postoperative Complications
Signs and Symptoms, Digestive
Signs and Symptoms
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013