- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00311350
Study Evaluating the Safety of MOA-728 Administered Orally to Healthy Subjects
November 21, 2019 updated by: Bausch Health Americas, Inc.
Ascending Multiple Dose Study of the Safety, Tolerability, and Pharmacokinetics of MOA-728 Administered Orally to Healthy Subjects
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
48
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19148
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy men and women
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Safety
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Jeff Cohn, Bausch Health Americas, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2006
Study Completion
August 1, 2006
Study Registration Dates
First Submitted
April 3, 2006
First Submitted That Met QC Criteria
April 3, 2006
First Posted (Estimate)
April 5, 2006
Study Record Updates
Last Update Posted (Actual)
November 25, 2019
Last Update Submitted That Met QC Criteria
November 21, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3200A3-100
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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