A Study in Healthy Volunteers to Assess Safety and Blood Levels of AZD9742 After Multiple Doses Over 14 Days
The purpose of this study is to determine the safety, tolerability and blood levels of AZD9742 after daily dosing for 14 days...
Brief Summary
Official Title: “A Phase I, Single Center, Double-blind Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Intravenous AZD9742 After Administration of Multiple Ascending Doses for 14 Days in Healthy Male and Female Subjects”
The purpose of this study is to determine the safety, tolerability and blood levels of AZD9742 after daily dosing for 14 days.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
- Study Primary Completion Date: August 2010
Intervention(s) in this Clinical Trial
- Drug: AZD9742
- IV infusion, 15 days
- Drug: Placebo
- IV infusion, 15 days
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- Placebo Comparator: 2
Outcome Measures for this Clinical Trial
Primary Measures
- Safety variables (adverse events, vital signs, physical examinations, clinical laboratory assessments, 12-lead ECG, digital ECG, telemetry)
- Time Frame: collected prior to treatment, during treatment and follow-up for a total of 25-30 days.
Safety Issue?: Yes
- Time Frame: collected prior to treatment, during treatment and follow-up for a total of 25-30 days.
Secondary Measures
- To characterize the Pharmacokinetics of AZD9742 in blood and urine
- Time Frame: PK-sampling during 14 pre-defined study days for PK profiling
Safety Issue?: No
- Time Frame: PK-sampling during 14 pre-defined study days for PK profiling
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- BMI between 19-30
Exclusion Criteria:
- Positive Fecal Occult Blood Test
- Prescriptions that inhibit liver function
- Received flu/H1N1 vaccine within 2 weeks before first dose
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 23 Years
Maximum Age for this Clinical Trial: 45 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Investigator Information
Lead Investigator: AstraZeneca Industry
Overall Clinical Trial Officials and Contacts
Andrew Shaw Study Director AstraZeneca
Overall Contact: Quntiles- Overland Park Kansas 1-800-292-5533 volunteer@quintiles.com
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01064388
Study ID Number: D2690C00002
ClinicalTrials.gov Identifier: NCT01064388
Health Authority: United States: Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01064388
