ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
A Study of the Safety of PAZ-417 in Healthy Elderly Adults

This study is currently recruiting participants.
Study NCT00663065.   Last updated on April 19, 2008.   Information provided by Wyeth

This Tabular View shows the required WHO registration data elements as marked by

Descriptive Information Fields
Brief Title  A Study of the Safety of PAZ-417 in Healthy Elderly Adults
Official Title  An Ascending Multiple-Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of PAZ-417 Administered Orally to Elderly Subjects
Brief Summary

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

Detailed Description
Study Phase Phase I
Study Type  Interventional
Study Design  Treatment, Randomized, Double Blind (Subject, Investigator), Single Group Assignment, Safety Study
Primary Outcome Measure  safety as determined by adverse events, ECGs, vitals signs, and laboratory test results [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measure  Drug distribution in the blood [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Condition  Healthy
Intervention  Drug: PAZ-417
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  40
Start Date  April 2008
Completion Date September 2008
Eligibility 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.
Gender Both
Ages 65 Years and older
Accepts Healthy Volunteers Yes
Contacts ††
Contact: Trial Manager         clintrialparticipation@wyeth.com    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00663065
Organization ID 3186A1-1102
Secondary IDs ††
Study Sponsor  Wyeth
Collaborators ††
Investigators 
Study Director:     Medical Monitor     Wyeth    
Information Provided By Wyeth
Verification Date April 2008
First Received Date  April 17, 2008
Last Updated Date April 19, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




Links to all studies - primarily for crawlers