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

NCT01154621 | Completed Phase 1

• 1 other identifier: D2690C00007
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tolerability; Healthy; Elderly

Keywords

Phase I; Double-blind; Randomized; Placebo-controlled study; Safety and tolerability of single intravenous dose of AZD9742 in healthy elderly volunteers

Outcome Measures

Primary Outcomes (1)

• To assess the safety and tolerability of a single intravenous dose of AZD9742 in healthy elderly adults.

  Adverse events, vital signs, electrocardiograms, telemetry, physical exams, and clinical laboratory assessments will be assessed prior to, during, and after treatment

  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.

Secondary Outcomes (1)

• 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.

Study Arms (2)

1

EXPERIMENTAL

Single dose of 750mg of intravenous AZD9742 in healthy elderly volunteers

Drug: AZD9742

2

PLACEBO COMPARATOR

Sterile 5% dextrose solution

Drug: Placebo

Interventions

AZD9742 DRUG

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

1

Placebo DRUG

Sterile 5% dextrose solution

2

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Springfield, Missouri, United States

Location

Study Officials

• Billings W Billings, MD

  Bio-Kinetic 1816 W. Mt Vernon, Springfield, MO 65802

  PRINCIPAL INVESTIGATOR

• Colleen Jensen

  AstraZeneca

  STUDY DIRECTOR

• Brendan Smyth

  AstraZeneca

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 28, 2010
• First Posted: July 1, 2010
• Study Start: June 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: August 3, 2010

Record last verified: 2010-08

Locations

US (1)