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

• ClinicalTrials.gov Identifier: NCT01154621
• Recruitment Status: Completed
• First Posted: July 1, 2010
• Last Update Posted: August 3, 2010
• Sponsor: AstraZeneca
• Information provided by: AstraZeneca

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 (Clinical Trial)
• 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: June 2010
• Actual Primary Completion Date: July 2010
• Actual Study Completion Date: July 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

Outcome Measures

Primary Outcome Measures :

1. To assess the safety and tolerability of a single intravenous dose of AZD9742 in healthy elderly adults. [ Time Frame: 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 :

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

Eligibility Criteria

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

Criteria

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

United States, Missouri

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

More Information

• Responsible Party: Medical Science Director, AstraZeneca Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT01154621
• Other Study ID Numbers: D2690C00007
• First Posted: July 1, 2010
• Last Update Posted: August 3, 2010
• Last Verified: August 2010

Keywords provided by AstraZeneca:

Phase I; Double-blind; Randomized; Placebo-controlled study; Safety and tolerability of single intravenous dose of AZD9742 in healthy elderly volunteers