A Study to Assess the Safety, Tolerability and Pharmacokinetics After Single Ascending Intravenous Doses of AZD2927 in Healthy Male Volunteers
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01264250
First received: December 7, 2010
Last updated: May 23, 2011
Last verified: May 2011
| Tracking Information | |||||||||||||
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| First Received Date ICMJE | December 7, 2010 | ||||||||||||
| Last Updated Date | May 23, 2011 | ||||||||||||
| Start Date ICMJE | January 2011 | ||||||||||||
| Primary Completion Date | May 2011 (final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||
| Change History | Complete list of historical versions of study NCT01264250 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | A Study to Assess the Safety, Tolerability and Pharmacokinetics After Single Ascending Intravenous Doses of AZD2927 in Healthy Male Volunteers | ||||||||||||
| Official Title ICMJE | A Phase I, Single-centre, Single-blind, Randomised, Placebo-controlled, Single-dose Study to Assess the Safety, Tolerability and Pharmacokinetics After Single Ascending Intravenous Doses of AZD2927 in Healthy Male Subjects | ||||||||||||
| Brief Summary | In this early phase study, healthy male volunteers will be randomly assigned to one dose of either AZD2927 or placebo. The objective will be to assess the Safety,Tolerability and Pharmacokinetics of AZD2927. |
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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 Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science |
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| Condition ICMJE | Healthy | ||||||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| 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 | ||||||||||||
| Estimated Enrollment ICMJE | 48 | ||||||||||||
| Completion Date | May 2011 | ||||||||||||
| Primary Completion Date | May 2011 (final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||||||||||
| Ages | 18 Years to 45 Years | ||||||||||||
| Accepts Healthy Volunteers | Yes | ||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
| Location Countries ICMJE | Sweden | ||||||||||||
| Administrative Information | |||||||||||||
| NCT Number ICMJE | NCT01264250 | ||||||||||||
| Other Study ID Numbers ICMJE | D4120C00001 | ||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||
| Responsible Party | MSD, AstraZeneca | ||||||||||||
| Study Sponsor ICMJE | AstraZeneca | ||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||
| Investigators ICMJE |
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| Information Provided By | AstraZeneca | ||||||||||||
| Verification Date | May 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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