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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01154621
First received: June 28, 2010
Last updated: August 2, 2010
Last verified: August 2010
  Purpose

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


Condition Intervention Phase
Tolerability
Healthy
Elderly
Drug: AZD9742
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]
    Adverse events, vital signs, electrocardiograms, telemetry, physical exams, and clinical laboratory assessments will be assessed prior to, during, and after treatment


Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: June 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01154621

Locations
United States, Missouri
Research Site
Springfield, Missouri, United States
Sponsors and Collaborators
AstraZeneca
Investigators
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
  More Information

No publications provided

Responsible Party: Medical Science Director, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01154621     History of Changes
Other Study ID Numbers: D2690C00007
Study First Received: June 28, 2010
Last Updated: August 2, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Phase I
Double-blind
Randomized
Placebo-controlled study
Safety and tolerability of single intravenous dose of AZD9742 in healthy elderly volunteers

ClinicalTrials.gov processed this record on April 17, 2014