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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01154621
Recruitment Status : Completed
First Posted : July 1, 2010
Last Update Posted : August 3, 2010
Information provided by:

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

Condition or disease Intervention/treatment Phase
Tolerability Healthy Elderly Drug: AZD9742 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : June 2010
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Arm Intervention/treatment
Experimental: 1
Single dose of 750mg of intravenous AZD9742 in healthy elderly volunteers
Drug: AZD9742
Sterile solution, 620 mg (20 mg/mL) in 50 mL vial with a fill volume of 31 mL

Placebo Comparator: 2
Sterile 5% dextrose solution
Drug: Placebo
Sterile 5% dextrose solution

Primary Outcome Measures :
  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 Outcome Measures :
  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. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01154621

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United States, Missouri
Research Site
Springfield, Missouri, United States
Sponsors and Collaborators
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Principal Investigator: Billings W Billings, MD Bio-Kinetic 1816 W. Mt Vernon, Springfield, MO 65802
Study Director: Colleen Jensen AstraZeneca
Study Chair: Brendan Smyth AstraZeneca
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Responsible Party: Medical Science Director, AstraZeneca Pharmaceuticals Identifier: NCT01154621    
Other Study ID Numbers: D2690C00007
First Posted: July 1, 2010    Key Record Dates
Last Update Posted: August 3, 2010
Last Verified: August 2010
Keywords provided by AstraZeneca:
Phase I
Placebo-controlled study
Safety and tolerability of single intravenous dose of AZD9742 in healthy elderly volunteers