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A Study of the Safety of PAZ-417 in Healthy Elderly Adults
This study is currently recruiting participants.
Verified by Wyeth, April 2008
First Received: April 17, 2008   Last Updated: April 19, 2008   History of Changes
Sponsored by: Wyeth
Information provided by: Wyeth
ClinicalTrials.gov Identifier: NCT00663065
  Purpose

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


Condition Intervention Phase
Healthy
Drug: PAZ-417
Phase I

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Single Group Assignment, Safety Study
Official Title: An Ascending Multiple-Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of PAZ-417 Administered Orally to Elderly Subjects

Further study details as provided by Wyeth:

Primary Outcome Measures:
  • safety as determined by adverse events, ECGs, vitals signs, and laboratory test results [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Drug distribution in the blood [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: April 2008
Estimated Study Completion Date: September 2008
Estimated Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
arm 1: Experimental Drug: PAZ-417

  Eligibility

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

Inclusion:

  1. A signed and dated IRB-approved informed consent form before any study specific screening procedures are performed.
  2. Ability to read English or Spanish.
  3. 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.
  4. Subjects should have a hemoglobin level greater than or equal to 12 g/dL at the screening visit.

Exclusion

  1. Any significant unstable or uncontrolled cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
  2. 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).
  3. Presence or history of symptomatic vertigo, significant cardiac valvular disease, congestive heart failure, angina pectoris significant cardiac arrhythmia, or seizures.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00663065

Contacts
Contact: Trial Manager clintrialparticipation@wyeth.com

Locations
United States, Arizona
Recruiting
Tempe, Arizona, United States, 85283
Sponsors and Collaborators
Wyeth
Investigators
Study Director: Medical Monitor Wyeth
  More Information

No publications provided

Responsible Party: Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers: 3186A1-1102
Study First Received: April 17, 2008
Last Updated: April 19, 2008
ClinicalTrials.gov Identifier: NCT00663065     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Wyeth:
Healthy subjects over 65
healthy subjects

Study placed in the following topic categories:
Healthy

ClinicalTrials.gov processed this record on May 07, 2009