NCT01064388CompletedPhase 1
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Safety variables (adverse events, vital signs, physical examinations, clinical laboratory assessments, 12-lead ECG, digital ECG, telemetry)
Study Overview
Brief Summary
The purpose of this study is to determine the safety, tolerability and blood levels of AZD9742 after daily dosing for 14 days.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 23 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
2
Placebo Comparator
Intervention: Placebo (Drug)
1
Experimental
Intervention: AZD9742 (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- To characterize the Pharmacokinetics of AZD9742 in blood and urine(PK-sampling during 14 pre-defined study days for PK profiling)
Investigators
Study Sites (1)
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