A Study of the Safety of PAZ-417 in Healthy Elderly Adults

NCT00663065 | Terminated Phase 1

• 1 other identifier: 3186A1-1102
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This is study to determine the safety of PAZ-417 in healthy adults over 65.

Conditions

Healthy

Keywords

Healthy subjects over 65; healthy subjects

Outcome Measures

Primary Outcomes (1)

• safety as determined by adverse events, ECGs, vitals signs, and laboratory test results

  6 months

Secondary Outcomes (1)

• Drug distribution in the blood

  6 months

Study Arms (1)

arm 1

EXPERIMENTAL

Drug: PAZ-417

Interventions

PAZ-417 DRUG

arm 1

Eligibility Criteria

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

You may qualify if:

• A signed and dated IRB-approved informed consent form before any study specific screening procedures are performed.
• Ability to read English or Spanish.
• Men or women greater than or equal to 65 years of age on study day 1. Women must be either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal for greater than or equal to 1 year (with estradiol less than or equal to 25 pg/mL\[92 pmol/L\] and FSH greather than or equal to 38 mIU/mL) and must have a negative serum pregnancy test result within 48 hours before administration of test article. Women who are surgically sterile must provide documentation of the procedure by an operative report or by ultrasound.
• Subjects should have a hemoglobin level greater than or equal to 12 g/dL at the screening visit.

You may not qualify if:

• Any significant unstable or uncontrolled cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
• History of vascular disorders (peripheral, coronary, venous), chronic inflammatory disorders (eg, rheumatoid arthritis), hematologic disorders, or bleeding disorders (eg, hemophilia, idiopathic thrombocytopenic purpura, VonWillebrand disease).
• Presence or history of symptomatic vertigo, significant cardiac valvular disease, congestive heart failure, angina pectoris significant cardiac arrhythmia, or seizures.

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

Study Sites (1)

Unknown Facility

Tempe, Arizona, 85283, United States

Location

Study Officials

• Medical Monitor

  Wyeth is now a wholly owned subsidiary of Pfizer

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: April 17, 2008
• First Posted: April 21, 2008
• Study Start: April 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: August 4, 2009

Record last verified: 2009-08

Locations

US (1)