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A Study Of The Safety, Tolerability, And Pharmacokinetics Of Multiple Doses Of PF-05180999 In Healthy Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01981486
Recruitment Status : Withdrawn
First Posted : November 11, 2013
Last Update Posted : May 23, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE November 5, 2013
First Posted Date  ICMJE November 11, 2013
Last Update Posted Date May 23, 2014
Study Start Date  ICMJE June 2014
Estimated Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 5, 2013)
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0-12 hours post-dose on Day 1 ]
    Single dose Cmax
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: 0-12 hours post-dose on Day 1 ]
    Single dose Tmax
  • Area Under the Curve from Time Zero to end of dosing interval (AUCtau) [ Time Frame: 0-12 hours post-dose on Day 1 ]
    Single dose AUCtau
  • Maximum Observed Plasma Concentration at Steady-State (Cmax,ss) [ Time Frame: 0-12 hours post-dose on Day 14 ]
    Steady-state Cmax
  • Time to Reach Maximum Observed Plasma Concentration at Steady-State (Tmax,ss) [ Time Frame: 0-12 hours post-dose on Day 14 ]
    Steady-state Tmax
  • Minimum Observed Plasma Trough Concentration at Steady-State (Cmin,ss) [ Time Frame: 0-12 hours post-dose on Day 14 ]
    Steady-state Cmin
  • Area Under the Curve from Time Zero to End of Dosing Interval at Steady-State (AUCtau,ss) [ Time Frame: 0-12 hours post-dose on Day 14 ]
    Steady-state AUCtau
  • Apparent Oral Clearance (CL/F) [ Time Frame: 0-48 hours post-final dose on Day 14 ]
    Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
  • Apparent Volume of Distribution (Vz/F) [ Time Frame: 0-48 hours post-final dose on Day 14 ]
    Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
  • Plasma Decay Half-Life (t1/2) [ Time Frame: 0-48 hours post-final dose on Day 14 ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
  • Accumulation Ratio (Racc) [ Time Frame: 0-12 hours post-dose on Days 1 and 14 ]
    Ratio of Day 14 AUCtau to Day 1 AUCtau
  • Amount Excreted in Urine (Ae) [ Time Frame: 0-12 hours post-dose on Day 14 ]
    Amount of drug excreted in urine
  • Percent of Dose Excreted in Urine (Ae%) [ Time Frame: 0-12 hours post-dose on Day 14 ]
    Percent of total dose excreted in urine
  • Renal Clearance (CLr) [ Time Frame: 0-48 hours post-dose on Day 14 ]
    Renal clearance is a quantitative measure of the rate at which a drug substance is removed from the blood via the renal route.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2013)
  • Identification of metabolites of PF-05180999 in urine and plasma [ Time Frame: 0-12 hours post-dose on Day 14 ]
    Metabolite identification
  • Change from Baseline in Total Leukocyte Levels and Leukocyte Subpopulations in Blister Fluid and Blood [ Time Frame: Day 13 and Day 14 ]
    Leukocyte levels in blister fluid and blood
  • Change from Baseline in Cytokine Levels in Blister Fluid [ Time Frame: Day 13 and Day 14 ]
    Cytokine levels in blister fluid
  • Time-Averaged Area Under the Effect Curve (AUEC/t) for Platelet cGMP and cAMP [ Time Frame: 0-12 hours post-dose on Day 1 and Day 14 ]
    Time-averaged area under the effect curve
  • AUEC/t Ratio [ Time Frame: 0-12 hours post-dose on Day 1 and Day 14 ]
    Ratio of Day 14 AUEC/t to Day 1 AUEC/t
  • Urinary 6beta-hydroxycortisol/cortisol ratio [ Time Frame: Day 14 ]
    Urinary marker of CYP3A induction
  • Plasma 4beta-hydroxycholesterol/cholesterol ratio [ Time Frame: Day 14 ]
    Plasma marker of CYP3A induction
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Of The Safety, Tolerability, And Pharmacokinetics Of Multiple Doses Of PF-05180999 In Healthy Adults
Official Title  ICMJE A Phase I, Placebo Controlled, Randomized, Subject-And Investigator-Blind, Sponsor-Open, Multiple Ascending Dose Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-05180999 In Healthy Adult Volunteers
Brief Summary PF-05180999 is a novel phosphodiesterase-2 (PDE2) inhibitor. The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of multiple doses of PF-05180999 administered twice daily over 14 days. Exploratory measures of PDE2 inhibition will also be evaluated in blood and blister fluid.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Migraine
Intervention  ICMJE
  • Drug: Placebo Tablets
    BID modified-release tablets
  • Drug: PF-05180999 Tablets
    BID modified-release tablets (20 to 240 mg BID)
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo tablets
    Intervention: Drug: Placebo Tablets
  • Experimental: PF-05180999
    Modified-release tablets of PF-05180999
    Intervention: Drug: PF-05180999 Tablets
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: May 21, 2014)
0
Original Estimated Enrollment  ICMJE
 (submitted: November 5, 2013)
62
Estimated Study Completion Date  ICMJE January 2015
Estimated Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male and/or female (of non-childbearing potential) subjects between the ages of 18 and 55 years
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs)

Exclusion Criteria:

  • Subjects with Gilbert's disease or screening laboratory test results that deviate from the upper and/or lower limits of the reference or acceptable range. The exception is that all liver function tests must not exceed the upper limit of normal.
  • Subjects with evidence of, or history of, hepatic disorder, including acute or chronic hepatitis B or hepatitis C.
  • Subjects with very light skin or very dark skin (at the discretion of the investigator).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01981486
Other Study ID Numbers  ICMJE B3441008
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date May 2014

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