- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00681317
AZD6280 Multiple Ascending Dose Study (MAD)
December 7, 2010 updated by: AstraZeneca
A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD6280 When Given in Multiple Ascending Oral Doses in Healthy Male and Healthy Female Subjects of Non-child Bearing Potential
This is a study to evaluate safety, tolerability, PK and PD effects of orally administered AZD6280 after single and repeated ascending doses.
Study Overview
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Pennsylvania
-
Philadelphia, Pennsylvania, United States
- Research Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Female subjects must be of non-child bearing potential.
Exclusion Criteria:
- Clinically significant illness within 2 weeks before the study start.
- Enrollment in another concurrent investigational study or intake of an investigational drug within 30 days or intake of an investigational drug within a period of 5 half lives of that drug prior to the screening visit
- Blood loss in excess of 200 mL within 30 days of Day -2, in excess of 400 mL within 90 days of Day -2, or in excess of 1200 mL within 1 year of Day -2
- Clinically relevant abnormalities in physical examinations, vital signs, ECG, clinical chemistry, hematology or urinalysis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
oral
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assess the safety and tolerability of multiple ascending oral doses of AZD7325 compared to placebo by assessment of adverse events, vital signs, physical examinations, laboratory parameters, and ECGs
Time Frame: Assessments are made at each visit, at least daily, during the study.
|
Assessments are made at each visit, at least daily, during the study.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluation and characterization of the pharmacokinetics of AZD6280
Time Frame: Blood samples will be taken during the study.
|
Blood samples will be taken during the study.
|
Evaluation of the pharmacodynamic effects of AZD6280
Time Frame: Test batteries will be performed at specified times both before and following study drug administration
|
Test batteries will be performed at specified times both before and following study drug administration
|
Identification of genes that influence the disposition, efficacy, safety and tolerability of AZD6280.
Time Frame: A single blood sample will be obtained.
|
A single blood sample will be obtained.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sylvan J. Hurewitz, MD, AstraZeneca Clinical Pharmacology Unit, US
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2008
Primary Completion (Actual)
July 1, 2008
Study Completion (Actual)
July 1, 2008
Study Registration Dates
First Submitted
May 19, 2008
First Submitted That Met QC Criteria
May 19, 2008
First Posted (Estimate)
May 21, 2008
Study Record Updates
Last Update Posted (Estimate)
December 9, 2010
Last Update Submitted That Met QC Criteria
December 7, 2010
Last Verified
December 1, 2010
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- D0850C00002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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