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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

April 17, 2008
August 3, 2009
April 2008
December 2008   (final data collection date for 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 ]
Same as current
Complete list of historical versions of study NCT00663065 on ClinicalTrials.gov Archive Site
Drug distribution in the blood [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of the Safety of PAZ-417 in Healthy Elderly Adults
An Ascending Multiple-Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of PAZ-417 Administered Orally to Elderly Subjects

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Healthy
Drug: PAZ-417
Experimental: arm 1
Intervention: Drug: PAZ-417
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
40
December 2008
December 2008   (final data collection date for primary outcome measure)

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.
Both
65 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00663065
3186A1-1102
No
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP