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

Healthy Clinical Trial

Official title:

An Ascending Multiple-Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of PAZ-417 Administered Orally to Elderly Subjects

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00663065
• Other study ID #: 3186A1-1102
• Status: Terminated
• Phase: Phase 1
• First received: April 17, 2008
• Last updated: August 3, 2009
• Start date: April 2008
• Est. completion date: December 2008

Study information

• Verified date: August 2009
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• PAZ-417

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety as determined by adverse events, ECGs, vitals signs, and laboratory test results		6 months	Yes
Secondary	Drug distribution in the blood		6 months	No