This is a Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of AZD9742 After Single IV Doses in Healthy Subjects

Phase 1

Completed

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

• Registration Number: NCT01030224
• Lead Sponsor: AstraZeneca

Brief Summary

The main purpose of this study is to assess the safety, tolerability and PK of AZD9742 after single IV doses.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-12-09
• Study First Submitted QC: 2009-12-10
• Study First Posted: 2009-12-11
• Status Verified: 2010-03
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Last Update Submitted: 2012-07-26
• Last Update Posted: 2012-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Provision of signed and dated, written informed consent prior to any study specific procedures.
• Clinically normal physical findings and laboratory values as judged by the investigator with normal ECG.
• Healthy male and female volunteers. Females must be of non childbearing potential.

Exclusion Criteria

• Clinically significant illness or clinically relevant trauma, as judged by the investigator, within 4 weeks of the first administration of the Investigational Product
• History of any disease or condition known to interfere with the absorption, distribution, metabolism or excretion of drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo to AZD9742 IV Infusion	Placebo to match AZD9742	Placebo
AZD9742 IV Infusion	AZD9742	Active

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of AZD9742 will be assessed by incidence and severity of AE's, abnormalities in vital signs, ECG's, telemetry, clinical laboratory assessments, physical exams and withdrawals	Assessments taken at Visit 1 (enrollment), defined timepoints pre-dose and post-dose during Visit 2 (residential period) and at Visit 3 (follow up). Volunteers will be monitored througout the study from Visit 1 through Visit 3 for adverse events.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic profile: to characterize the pharmacokinetics of AZD9742 in blood and urine	Samples taken during Visit 2 (residential period) at defined timepoints pre-dose and post-dose.

Trial Locations

Locations (1)

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