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Sponsored by: |
AstraZeneca |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00785915 |
This is a Phase I randomized double-blind, placebo-controlled, single and multiple ascending dose study to assess the safety, tolerability and pharmacokinetics of AZD6765 in healthy male and female Japanese and Caucasian subjects
Condition | Intervention | Phase |
---|---|---|
Healthy |
Drug: AZD6765 Drug: Placebo |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety Study |
Official Title: | A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD6765 in Healthy Male and Female Japanese and Caucasian Subjects |
Estimated Enrollment: | 40 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: AZD6765
single administration and once daily for 5 days
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2: Placebo Comparator
given (2 subjects in each ethnic/dose group)
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Drug: Placebo
single administration and once daily for 5 days
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Ages Eligible for Study: | 20 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Parexel International - Baltimore CPRU | 410-350-7918 | Betsy.GeishenScott@parexel.com |
United States, California | |
Research Site | Recruiting |
GLENDALE, California, United States | |
United States, Maryland | |
Research Site | Not yet recruiting |
BALTIMORE, Maryland, United States |
Principal Investigator: | Mark Yen, MD | California Clinical Trials |
Responsible Party: | AstraZeneca LP ( United States: Institutional Review Board ) |
Study ID Numbers: | D6702C00013 |
Study First Received: | November 3, 2008 |
Last Updated: | December 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00785915 |
Health Authority: | United States: Food and Drug Administration |
AZD6765 Japanese and Caucasian Healthy Volunteers Phase I study Single and multiple Ascending Dose Japanese volunteers |
Healthy |