Assessing the Safety and Tolerability of a Single IV Dose of AZD9742 in Healthy Elderly Male and Female Subjects

A Phase I, Double-blind, Randomized, Placebo-Controlled Study to Assess the Safety and Tolerability, and Pharmacokinetics of a Single Dose of AZD9742 in Healthy Elderly Male and Female Volunteers

The aim of this study is to examine the safety and tolerability of a single dose of AZD9742 in elderly individuals.

Study Overview

• Status: Completed
• Conditions: Healthy; Elderly; Tolerability
• Intervention / Treatment: Drug: AZD9742; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Springfield, Missouri, United States
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male and female volunteers at age of 65 years or older with suitable veins for cannulation or repeated venipuncture, in good health (based on medical history and physical examination and clinical laboratory tests) as judged by the investigator.
• Female volunteers must be postmenopausal (cessation of regular menses for 12 months and a follicle stimulating hormone level of more than 40IU/L abd estradiol of less than 20ng/mL.
• Male volunteers should be willing to use barrier contraception, ie, condoms, from the day of dosing until 3 months after dosing with the investigational product.

Exclusion Criteria:

• History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate
• History or presence of GI, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs as judged by Investigator.
• Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational product

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Single dose of 750mg of intravenous AZD9742 in healthy elderly volunteers	Drug: AZD9742; Sterile solution, 620 mg (20 mg/mL) in 50 mL vial with a fill volume of 31 mL
Placebo Comparator: 2; Sterile 5% dextrose solution	Drug: Placebo; Sterile 5% dextrose solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the safety and tolerability of a single intravenous dose of AZD9742 in healthy elderly adults.	Adverse events, vital signs, electrocardiograms, telemetry, physical exams, and clinical laboratory assessments will be assessed prior to, during, and after treatment	The screening period is up to 28 days. Residential period will be a total of 5 days. Follow up will occur between 5 and 10 days after discharge.

Secondary Outcome Measures

Outcome Measure	Time Frame
To evaluate the pharmacokinetics of a single intravenous dose of AZD9742 in healthy elderly volunteers	Blood and urine samples will be collected for the 4 days while in residence.

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: Colleen Jensen, AstraZeneca; Principal Investigator: Billings W Billings, MD, Bio-Kinetic 1816 W. Mt Vernon, Springfield, MO 65802

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: June 28, 2010
• First Submitted That Met QC Criteria: June 30, 2010
• First Posted (Estimate): July 1, 2010

Study Record Updates

• Last Update Posted (Estimate): August 3, 2010
• Last Update Submitted That Met QC Criteria: August 2, 2010
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Keywords: Randomized; Double-blind; Phase I; Placebo-controlled study; Safety and tolerability of single intravenous dose of AZD9742 in healthy elderly volunteers
• Other Study ID Numbers: D2690C00007