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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00803855 |
The primary purpose of this study is to assess the safety and tolerability of AZD1446 following single dose administration.
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: AZD1446 |
Phase I |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Double Blind (Subject, Investigator), Single Group Assignment, Safety Study |
Official Title: | 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 |
Estimated Enrollment: | 82 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
AZD1446 Oral or placebo: Experimental
Single oral administration of AZD1446 or placebo
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Drug: AZD1446
oral, single dose
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AZD1446 Oral, with or without food: Experimental
Single oral administration of AZD1446 with or without food
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Drug: AZD1446
oral, single dose
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Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lena Bolin, SDD | +46 8 553 26000 | lena.bolin@astrazeneca.com |
Sweden | |
Research site | Recruiting |
Huddinge, Sweden |
Study Director: | Didier Meulien, MD, PhD, MSD | AstraZeneca Södertälje |
Principal Investigator: | Ingemar Bylesjö, MD, PhD | AstraZeneca CPU Huddinge |
Responsible Party: | AstraZeneca R&D Södertälje ( Didier Meulien, MD, PhD, Medical Science Director, Clinical Neuroscience, Therapeutic area Alzheimers Disease and Cognition ) |
Study ID Numbers: | D1950C00001, EudraCT No.: 2008-006228-76 |
Study First Received: | December 5, 2008 |
Last Updated: | December 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00803855 |
Health Authority: | Sweden: Medical Products Agency; Sweden: Regional Ethical Review Board |
single dose pharmacokinetics safety |
healthy volunteers food interaction AZD1446 |
Healthy |