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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT01154621

Collaborator

(none)

Enrollment

Location

Arms

Duration (Days)

12.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Tolerability Healthy Elderly	Drug: AZD9742 Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2010

Actual Primary Completion Date :

Jul 1, 2010

Actual Study Completion Date :

Jul 1, 2010

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

To assess the safety and tolerability of a single intravenous dose of AZD9742 in healthy elderly adults. [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.]
Adverse events, vital signs, electrocardiograms, telemetry, physical exams, and clinical laboratory assessments will be assessed prior to, during, and after treatment

Secondary Outcome Measures

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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Springfield	Missouri	United States

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator: Billings W Billings, MD, Bio-Kinetic 1816 W. Mt Vernon, Springfield, MO 65802
Study Director: Colleen Jensen, AstraZeneca
Study Chair: Brendan Smyth, AstraZeneca