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

AstraZeneca logo

AstraZeneca

Status and phase

Completed
Phase 1

Conditions

Healthy
Elderly
Tolerability

Treatments

Drug: AZD9742
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01154621
D2690C00007

Details and patient eligibility

About

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

Enrollment

12 patients

Sex

All

Ages

65+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Quadruple Blind

12 participants in 2 patient groups, including a placebo group

1
Experimental group
Description:
Single dose of 750mg of intravenous AZD9742 in healthy elderly volunteers
Treatment:
Drug: AZD9742
2
Placebo Comparator group
Description:
Sterile 5% dextrose solution
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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