Study to Assess Safety, Tolerability and Pharmacokinetics After Single Doses of AZD1446 to Healthy Volunteers (SAD)
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00803855
First received: December 5, 2008
Last updated: May 14, 2009
Last verified: May 2009
| Tracking Information | |||||||||
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| First Received Date ICMJE | December 5, 2008 | ||||||||
| Last Updated Date | May 14, 2009 | ||||||||
| Start Date ICMJE | December 2008 | ||||||||
| Primary Completion Date | April 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Safety and tolerability of AZD1446 by assessment of serious adverse events, ECGs, vital signs and laboratory variables [ Time Frame: From first to last visit ] [ Designated as safety issue: Yes ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00803855 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 | Study to Assess Safety, Tolerability and Pharmacokinetics After Single Doses of AZD1446 to Healthy Volunteers | ||||||||
| Official Title ICMJE | A Phase I, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Single Ascending Dose Study to Asses the Safety, Tolerability, Pharmacokinetics of AZD1446 Including an Open Food Effect Panel in Healthy Male and Non-Fertile Female Volunteers | ||||||||
| Brief Summary | The primary purpose of this study is to assess the safety and tolerability of AZD1446 following single dose administration. |
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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: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science |
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| Condition ICMJE | Healthy | ||||||||
| Intervention ICMJE | Drug: AZD1446
oral, single dose |
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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 | ||||||||
| Enrollment ICMJE | 110 | ||||||||
| Completion Date | April 2009 | ||||||||
| Primary Completion Date | April 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion 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 | Sweden | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00803855 | ||||||||
| Other Study ID Numbers ICMJE | D1950C00001, EudraCT No.: 2008-006228-76 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Didier Meulien, MD, PhD, Medical Science Director, Clinical Neuroscience, Therapeutic area Alzheimers Disease and Cognition, AstraZeneca R&D Södertälje | ||||||||
| Study Sponsor ICMJE | AstraZeneca | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | AstraZeneca | ||||||||
| Verification Date | May 2009 | ||||||||
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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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