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Completed

NCT Number: NCT01154621

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

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

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Springfield, Missouri, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD9742

Drug

Sterile solution, 620 mg (20 mg/mL) in 50 mL vial with a fill volume of 31 mL

Placebo

Drug

Sterile 5% dextrose solution

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jul 1, 2010
Registry last updated
Aug 3, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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