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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: AZD9742; Drug: Placebo

• Registration Number: NCT01064388
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this study is to determine the safety, tolerability and blood levels of AZD9742 after daily dosing for 14 days.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-03
• Study First Submitted QC: 2010-02-05
• Study First Posted: 2010-02-08
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-05
• Last Update Posted: 2012-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	AZD9742	-
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
Safety variables (adverse events, vital signs, physical examinations, clinical laboratory assessments, 12-lead ECG, digital ECG, telemetry)	collected prior to treatment, during treatment and follow-up for a total of 25-30 days.

Secondary Outcome Measures

Name	Time	Method
To characterize the Pharmacokinetics of AZD9742 in blood and urine	PK-sampling during 14 pre-defined study days for PK profiling

Trial Locations

Locations (1)

Research Site; 🇺🇸 Overland Park, Kansas, United States