A Study To Look At Safety And Blood Concentrations After Multiple Doses Of PF-03382792 In Healthy Elderly Individuals

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01089738
First received: March 17, 2010
Last updated: July 6, 2010
Last verified: July 2010
  Purpose

This study is designed to look at the safety and blood concentrations of PF-03382792 in healthy elderly subjects after taking multiple doses for 14 days.


Condition Intervention Phase
Healthy
Drug: PF-03382792 0.5mg
Drug: PF-03382792 1.5 mg
Drug: PF-03382792 5 mg
Drug: PF-03382792 15 mg
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: An Investigator And Subject-Blind Phase 1 Study To Characterize The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Doses Of PF-03382792 In Healthy Elderly Subjects

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Safety Endpoints include: AEs, vital signs, triplicate ECGs, [ Time Frame: Day 0 to Day 28 ] [ Designated as safety issue: Yes ]
  • Safety Endpoints include: Cosyntropin Stimulation Test, Clinical Examinations, Slit Lamp Examination, Aldosterone Concentrations [ Time Frame: Day 0 to Day 28 ] [ Designated as safety issue: Yes ]
  • Safety Endpoints include: safety laboratory endpoints (including a complete blood count and a full chemistry panel, including electrolytes, hepatic transaminases, and urinalysis, with microscopic analysis if dipstick analysis is positive), [ Time Frame: Day 0 to Day 28 ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic endpoints include: Plasma concentrations of PF 03382792 and its N dealkylated metabolite, PF 03227077, will be measured and used to determine Cmax, Tmax, AUC on Day 1 and Css,max, Tss,max, AUC, Css,min, Css,avg on Days 7 and 14. [ Time Frame: Day 0 to Day 28 ] [ Designated as safety issue: No ]
  • Additional pharmacokinetic endpoints: the accumulation ratio (Rac) will be determined from Day 14 and Day 1 AUC. If data permit, t1/2 and urinary excretion parameters (CLR for the parent and Ae and Ae%) will be calculated. [ Time Frame: Day 0 to Day 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • No secondary outcomes [ Time Frame: No secondary outcomes ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: November 2010
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dosing
Ascending Doses
Drug: PF-03382792 0.5mg
0.5 mg PF-03382792, qd, for 14 days or placebo
Drug: PF-03382792 1.5 mg
1.5 mg PF-03382792, qd, for 14 days or placebo
Drug: PF-03382792 5 mg
5 mg PF-03382792, qd, for 14 days or placebo
Drug: PF-03382792 15 mg
15 mg PF-03382792, qd, for 14 days or placebo

Detailed Description:

To examine safety, toleratibilty and pharmacokinetics of PF-03382792 in healthy elderly subjects.

  Eligibility

Ages Eligible for Study:   65 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteer aged 65-80 years old
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2
  • Total body weight >50 kg (110 lbs).

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  • Subjects with symptoms or signs of adrenal insufficiency.
  • Subjects with clinically significant ocular lens abnormalities as detected by the investigator based on the findings of a slit lamp examination performed by an ophthalmologist.
  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: NCT01089738

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01089738     History of Changes
Other Study ID Numbers: B1651003
Study First Received: March 17, 2010
Last Updated: July 6, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
mulitple dose
pharmacokinetics
safety
healthy elderly volunteers

ClinicalTrials.gov processed this record on October 23, 2014