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This study has been withdrawn prior to enrollment.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

March 17, 2010
July 6, 2010
November 2010
April 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01089738 on ClinicalTrials.gov Archive Site
No secondary outcomes [ Time Frame: No secondary outcomes ] [ Designated as safety issue: No ]
No secondary outcomes [ Time Frame: No secondary outcomes ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study To Look At Safety And Blood Concentrations After Multiple Doses Of PF-03382792 In Healthy Elderly Individuals
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

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.

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

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Healthy
  • 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
Experimental: Dosing
Ascending Doses
Interventions:
  • Drug: PF-03382792 0.5mg
  • Drug: PF-03382792 1.5 mg
  • Drug: PF-03382792 5 mg
  • Drug: PF-03382792 15 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
40
April 2011
April 2011   (final data collection date for primary outcome measure)

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.
Both
65 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01089738
B1651003
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2010

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