A Study in Healthy Volunteers to Assess Safety and Blood Levels of AZD5847 After Multiple Doses Over 14 Days

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: AZD5847; Drug: Placebo

• Registration Number: NCT01116258
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this study is to determine the safety, tolerability and blood levels of AZD5847 after daily oral dosing for 14 days.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-29
• Study First Submitted QC: 2010-05-03
• Study First Posted: 2010-05-04
• Status Verified: 2010-10
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Last Update Submitted: 2010-10-08
• Last Update Posted: 2010-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• BMI between 18-30

Exclusion Criteria

• Use of drugs that inhibit or induce cytochrome P450 3A4 enzymes
• History of presence of gastrointestinal, hepatic or renal disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	AZD5847	-
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 to 52 days(includes upto 28 days for screening)

Secondary Outcome Measures

Name	Time	Method
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