Elderly, Healthy, Tolerability
Conditions
Keywords
Phase I, Double-blind, Randomized, Placebo-controlled study, Safety and tolerability of single intravenous dose of AZD9742 in healthy elderly volunteers
Brief summary
The aim of this study is to examine the safety and tolerability of a single dose of AZD9742 in elderly individuals.
Interventions
DRUGAZD9742
Sterile solution, 620 mg (20 mg/mL) in 50 mL vial with a fill volume of 31 mL
DRUGPlacebo
Sterile 5% dextrose solution
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| 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. |
Countries
United States
Outcome results
None listed