Study Evaluating the Safety of MOA-728 Administered Orally to Healthy Subjects
This study has been completed.
Sponsor:
Salix Pharmaceuticals
Information provided by:
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00311350
First received: April 3, 2006
Last updated: July 22, 2011
Last verified: July 2011
| Tracking Information | |||||
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| First Received Date ICMJE | April 3, 2006 | ||||
| Last Updated Date | July 22, 2011 | ||||
| Start Date ICMJE | March 2006 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Safety | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00311350 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study Evaluating the Safety of MOA-728 Administered Orally to Healthy Subjects | ||||
| Official Title ICMJE | Ascending Multiple Dose Study of the Safety, Tolerability, and Pharmacokinetics of MOA-728 Administered Orally to Healthy Subjects | ||||
| Brief Summary | 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety Study Masking: Double-Blind |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: MOA-728 | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 48 | ||||
| Completion Date | August 2006 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 50 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00311350 | ||||
| Other Study ID Numbers ICMJE | 3200A3-100 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Jeff Cohn, Salix Pharmaceuticals | ||||
| Study Sponsor ICMJE | Salix Pharmaceuticals | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Salix Pharmaceuticals | ||||
| Verification Date | July 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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