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

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

Official Title
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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

Conditions
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Tolerability, Healthy, Elderly

Intervention / Treatment
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* Drug: AZD9742
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | Measure Description | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase I, Double-blind, Randomized, Placebo-controlled study, Safety and tolerability of single intravenous dose of AZD9742 in healthy elderly volunteers