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

This study has been terminated.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00663065
First received: April 17, 2008
Last updated: August 3, 2009
Last verified: August 2009
  Purpose

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


Condition Intervention Phase
Healthy
Drug: PAZ-417
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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 is now a wholly owned subsidiary of Pfizer:

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
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: arm 1 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00663065

Locations
United States, Arizona
Tempe, Arizona, United States, 85283
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00663065     History of Changes
Other Study ID Numbers: 3186A1-1102
Study First Received: April 17, 2008
Last Updated: August 3, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Healthy subjects over 65
healthy subjects

ClinicalTrials.gov processed this record on July 29, 2014