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Trial record 1 of 1 for:    NCT01914796
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A Phase I Trial to Investigate the Safety and Tolerability of PF-06412562

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ClinicalTrials.gov Identifier: NCT01914796
Recruitment Status : Completed
First Posted : August 2, 2013
Last Update Posted : May 23, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE July 31, 2013
First Posted Date  ICMJE August 2, 2013
Last Update Posted Date May 23, 2014
Study Start Date  ICMJE August 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2014)
  • Plasma Decay Half-Life (t1/2) [ Time Frame: 0, 0.5, 1, 1.5, 2, 4, 5, 6, 8, 9, 10, 12, 16, 24, 32 hours post-dose ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 0, 0.5, 1, 1.5, 2, 4, 5, 6, 8, 9, 10, 12, 16, 24, 32 hours post-dose ]
    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0, 0.5, 1, 1.5, 2, 4, 5, 6, 8, 9, 10, 12, 16, 24, 32 hours post-dose ]
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [ Time Frame: 0, 0.5, 1, 1.5, 2, 4, 5, 6, 8, 9, 10, 12, 16, 24, 32 hours post-dose ]
    AUC = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time. It is obtained from AUC (0 - t) plus AUC (t - 8).
  • Apparent Oral Clearance (CL/F) [ Time Frame: 0, 0.5, 1, 1.5, 2, 4, 5, 6, 8, 9, 10, 12, 16, 24, 32 hours post-dose ]
    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. Clearance was estimated from population pharmacokinetic (PK) modeling. 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, 0.5, 1, 1.5, 2, 4, 5, 6, 8, 9, 10, 12, 16, 24, 32 hours post-dose ]
    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.
  • Measurement of Cognitive Decline by Means of a Computerized Battery of Neuropsychologic Tests [ Time Frame: 0, 1, 4, 8, 12 hours post-dose ]
    Change from baseline cognitive performance
  • Eye Blink Rate [ Time Frame: 0, 1, 2, 4 and 8 hours ]
    Measurement of eye blink rate for a given dose at time of predicted maximum blood concentration of the compound.
  • Area Under the Curve From Time Zero to 24 hours [ Time Frame: 0, 0.5, 1, 1.5, 2, 4, 5, 6, 8, 9, 10, 12, 16, 24 hours post-dose ]
    Area under the plasma concentration time-curve from zero to 24 hours
Original Primary Outcome Measures  ICMJE
 (submitted: July 31, 2013)
  • Plasma Decay Half-Life (t1/2) [ Time Frame: 0, 0.5, 1, 1.5, 2, 4, 5, 6, 8, 9, 10, 12, 16, 24, 32 hours post-dose ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: 0, 0.5, 1, 1.5, 2, 4, 5, 6, 8, 9, 10, 12, 16, 24, 32 hours post-dose ]
    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 0, 0.5, 1, 1.5, 2, 4, 5, 6, 8, 9, 10, 12, 16, 24, 32 hours post-dose ]
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [ Time Frame: 0, 0.5, 1, 1.5, 2, 4, 5, 6, 8, 9, 10, 12, 16, 24, 32 hours post-dose ]
    AUC = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time. It is obtained from AUC (0 - t) plus AUC (t - 8).
  • Apparent Oral Clearance (CL/F) [ Time Frame: 0, 0.5, 1, 1.5, 2, 4, 5, 6, 8, 9, 10, 12, 16, 24, 32 hours post-dose ]
    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. Clearance was estimated from population pharmacokinetic (PK) modeling. 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, 0.5, 1, 1.5, 2, 4, 5, 6, 8, 9, 10, 12, 16, 24, 32 hours post-dose ]
    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.
  • Measurement of Cognitive Decline by Means of a Computerized Battery of Neuropsychologic Tests [ Time Frame: 0, 1, 4, 8, 12 hours post-dose ]
    Change from baseline cognitive performance
  • Eye Blink Rate [ Time Frame: 0, 1, 2, 4 and 8 hours ]
    Measurement of eye blink rate for a given dose at time of predicted maximum blood concentration of the compound.
  • Relative Bioavailibility [ Time Frame: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24 and 32 hours ]
    Reference instantaneous release at equivalent extemporaneously-prepared osmotic capsule dose: AUCinf,EPOC/AUCinf,IR
  • Area Under the Curve From Time Zero to 24 hours [ Time Frame: 0, 0.5, 1, 1.5, 2, 4, 5, 6, 8, 9, 10, 12, 16, 24 hours post-dose ]
    Area under the plasma concentration time-curve from zero to 24 hours
  • Peak-to-Trough Ratio [ Time Frame: 0 and 12 hours ]
    Peak-to-Trough ratio is calculated as Cmax / Cmin, where Cmax is measured at the max concentration and Cmin is measured 12 hours after dose.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase I Trial to Investigate the Safety and Tolerability of PF-06412562
Official Title  ICMJE A Phase 1, Double Blind, Sponsor Open, Randomized, Placebo Controlled, Crossover, Single Oral Dose Escalation Study To Investigate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-06412562 In Healthy Subjects
Brief Summary This study will determine the safety and tolerability of PF-06412562 given orally to healthy volunteers. To determine the optimal dose for future studies, the concentration of the drug over time will be determined by periodic blood samples. The rate of eye blinks will be measured as an indicator of PF-06412562 action on the receptors of interest in the brain.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: PF-06412562
    Single doses, given by oral solution, starting at 0.5 mg up to a possible maximum of 150 mg. The subject will have been fasted for 10 hours prior to the single dose. Two doses, 120 mg and 150 mg, will be split into 3 doses such that the total dose is given over 8 hours (i.e. t = 0, 4, and 8 hours). For each dosing period, 2 subjects will be given a placebo as a comparator. One dose will be given in the fed state.
  • Drug: PF-06412562
    It is believed that for increasing doses of this compound the eye blink rate (EBR) will also increase. This arm will use EBR measurement technology to verify this hypothesis. In each dosing period, 4 subjects will be given a placebo as a comparator.
Study Arms  ICMJE
  • Placebo Comparator: Single ascending doses
    Intervention: Drug: PF-06412562
  • Placebo Comparator: Measurement of eye blink rate
    Intervention: Drug: PF-06412562
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 Completed
Actual Enrollment  ICMJE
 (submitted: February 5, 2014)
39
Original Estimated Enrollment  ICMJE
 (submitted: July 31, 2013)
38
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years

Female subjects of non childbearing potential that meet at least one of the following criteria:

Achieved postmenopausal status, defined as: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum follicle stimulating hormone (FSH) level confirming the postmenopausal status;

  • Have undergone a documented hysterectomy and/or bilateral oophorectomy;
  • Have medically confirmed ovarian failure.

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).

Any condition possibly affecting drug absorption .

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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01914796
Other Study ID Numbers  ICMJE B7441001
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 February 2014

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