A Single Dose Study Of PF-06678552 In Healthy Subjects

• ClinicalTrials.gov Identifier: NCT01992614
• Recruitment Status: Completed
• First Posted: November 25, 2013
• Last Update Posted: March 28, 2014
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: November 19, 2013
• First Posted Date: November 25, 2013
• Last Update Posted Date: March 28, 2014
• Study Start Date: December 2013
• Actual Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 19, 2013): Assessment of adverse events (AEs), clinical laboratory tests, vital signs (including blood pressure and pulse rate) and cardiac conduction intervals as assessed via 12-lead electrocardiogram (ECG). [ Time Frame: 0 to 72 hours post dose ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 19, 2013)

• Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06678552 [ Time Frame: 0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose ]
  Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
• Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - infinity)] for PF-06678552 [ Time Frame: 0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose ]
  AUC (0 - infinity)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity).
• Maximum Observed Plasma Concentration (Cmax) for for PF-06678552 [ Time Frame: 0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose ]
  Maximum Observed Plasma Concentration (Cmax)
• Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06678552 [ Time Frame: 0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose ]
  Time to Reach Maximum Observed Plasma Concentration (Tmax)
• Plasma Decay Half-Life (t1/2) for PF-06678552 [ Time Frame: 0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose ]
  Plasma Decay Half-Life (t1/2)
• Apparent Oral Clearance (CL/F) for PF-06678552 [ Time Frame: 0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 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. 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) for PF-06678552 [ Time Frame: 0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 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.
• Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06644927 [ Time Frame: 0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose ]
  Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
• Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - infinity)] for PF-06644927 [ Time Frame: 0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose ]
  AUC (0 - infinity)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - infinity). It is obtained from AUC (0 - t) plus AUC (t - infinity).
• Maximum Observed Plasma Concentration (Cmax) for PF-06644927 [ Time Frame: 0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose ]
  Maximum Observed Plasma Concentration (Cmax)
• Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06644927 [ Time Frame: 0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose ]
  Time to Reach Maximum Observed Plasma Concentration (Tmax)
• Plasma Decay Half-Life (t1/2) for PF-06644927 [ Time Frame: 0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose ]
  Plasma Decay Half-Life (t1/2)
• Amount of PF-06644927 excreted in the urine (Ae) [ Time Frame: 0-4, 4-12, and 12-24 hours post dose ]
  Amount of drug excreted in the urine is a measure of the degree that the kidneys filter drug from the blood to the urine.
• Percent of PF-06678552 dose excreted in the urine as PF-06644927 (Ae%) [ Time Frame: 0-4, 4-12, and 12-24 hours post dose ]
  The percent of PF-06678552 dose excreted in the urine as PF-06644927 is calculated from the mass of dose excreted in the urine compared to the total dose of PF-06678552 and corrected for the relative weight of PF-06644927 to PF-06678552.
• Renal Clearance (CLr) for PF-06644927 [ Time Frame: 0-4, 4-12, and 12-24 hours post dose ]
  Renal clearance is the measure of the rate of drug moving into the urine from blood

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Single Dose Study Of PF-06678552 In Healthy Subjects
• Official Title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study To Assess The Safety, Tolerability, And Pharmacokinetics Of PF-06678552 After Fed And Fasted Administration Of Single Escalating Oral Doses In Healthy Subjects
• Brief Summary: PF-06678552 is a new compound proposed for the treatment of hypercholesteremia. The primary purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of single oral doses of PF-06678552 in healthy subjects.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Basic Science
• Condition: Healthy

Intervention

Drug: PF-06678552 or Placebo

PF-06678552 or placebo will be administered as an extemporaneously prepared solution once in each period.

Study Arms

• Experimental: Cohort 1
  Single ascending doses of PF-06678552 or placebo to investigate the safety, tolerability, PK, and PD.
  Intervention: Drug: PF-06678552 or Placebo
• Experimental: Cohort 2
  Single ascending doses of PF-06678552 or placebo to investigate the safety, tolerability, PK, and PD.
  Intervention: Drug: PF-06678552 or Placebo
• Experimental: Cohort 3
  Single ascending doses of PF-06678552 or placebo to investigate the safety, tolerability, PK, and PD.
  Intervention: Drug: PF-06678552 or Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 27, 2014): 24
• Original Estimated Enrollment (submitted: November 19, 2013): 36
• Actual Study Completion Date: March 2014
• Actual Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Healthy male and/or female subjects of non childbearing potential.
• Body Mass Index (BMI) of 18 to 30.5 kg/m2; and a total body weight >50 kg
• Low density lipoprotein cholesterol between 115 mg/dL and 190 mg/dL

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium

Administrative Information

• NCT Number: NCT01992614
• Other Study ID Numbers: B7611001
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Pfizer
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: March 2014