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

Phase 1

Completed

• Conditions: Tolerability; Healthy; Elderly
• Interventions: Drug: AZD9742; Drug: Placebo

• Registration Number: NCT01154621
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-28
• Study First Submitted QC: 2010-06-30
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Study First Posted: 2010-07-01
• Status Verified: 2010-08
• Last Update Submitted: 2010-08-02
• Last Update Posted: 2010-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	AZD9742	Single dose of 750mg of intravenous AZD9742 in healthy elderly volunteers
2	Placebo	Sterile 5% dextrose solution

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Research Site; 🇺🇸 Springfield, Missouri, United States