Assessment of the Safety of ABT-308 in Healthy Volunteers and Subjects With Asthma - NCT00986037-90630 (Clinical Trial 403494)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy403494.aspx
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| City: |
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Cypress |
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State:
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CA |
| Zip Code: |
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90630 |
| Conditions: |
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Asthma |
| Purpose: |
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The primary purpose of this study is to determine the safety, tolerability and
pharmacokinetics of ABT-308 in healthy volunteers and patients with mild to moderate
controlled asthma.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- Healthy volunteers:
1. A condition of good health based upon the results of medical history, physical
examination, vital signs, laboratory profile and ECG.
2. BMI 18 to 29, inclusive.
- Mild asthma patients:
1. Diagnosis of well-controlled, mild to moderate asthma by GINA guidelines for >
or = to 6 months
2. A condition of good health (than mild to moderate asthma) based upon the results
of medical history, physical examination, vital signs laboratory profile and
EDG.
3. BMI 18 to 34, inclusive.
Exclusion Criteria:
1. Asthma exacerbation within 8 weeks of Study Day 1.
2. Clinically significant allergic reaction to any drug, biologic, food, or vaccine.
3. History of allergic reaction or significant sensitivity to constituents of study
drug.
4. Receipt of any investigational product within 30 days or 5 half-lives (whichever is
longer) prior to study drug administration.
5. Subject is a smoker or has a history of smoking within the 6-month period preceding
study drug administration.
6. Current enrollment in another clinical study. |
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| Study is available at: |
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Cypress, CA 90630
United States
Primary Contact:
Email: javierq@wcctrials.com
Phone: 714-252-0700
Secondary Contact:
Susan Weszt
Email: susan.weszt@abbott.com
Phone: 847-938-6572 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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