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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00311350
First Posted: April 5, 2006
Last Update Posted: July 25, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Valeant Pharmaceuticals International, Inc.
  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
Masking: Double
Official Title: Ascending Multiple Dose Study of the Safety, Tolerability, and Pharmacokinetics of MOA-728 Administered Orally to Healthy Subjects

Further study details as provided by Valeant Pharmaceuticals International, Inc.:

Primary Outcome Measures:
  • Safety

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy men and women
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00311350


Locations
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19148
Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.
Investigators
Study Director: Jeff Cohn Valeant Pharmaceuticals International, Inc.
  More Information

Responsible Party: Jeff Cohn, Salix Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00311350     History of Changes
Other Study ID Numbers: 3200A3-100
First Submitted: April 3, 2006
First Posted: April 5, 2006
Last Update Posted: July 25, 2011
Last Verified: July 2011

Keywords provided by Valeant Pharmaceuticals International, Inc.:
Safety
Health
Pharmacokinetics
ileus

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