A Study in Healthy Volunteers to Assess Safety and Blood Levels of AZD9742 After Multiple Doses Over 14 Days

AstraZeneca36 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Healthy

Interventions

AZD9742DRUG

IV infusion, 15 days

PlaceboDRUG

IV infusion, 15 days

Eligibility

Sex: ALLMin age: 23 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Research Site

Overland Park, Kansas, United States

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

Time frame: PK-sampling during 14 pre-defined study days for PK profiling

Data from ClinicalTrials.gov

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