A Single Dose Study Of PF-06678552 In Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01992614
First received: November 19, 2013
Last updated: March 27, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: PF-06678552 or Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Renal clearance is the measure of the rate of drug moving into the urine from blood


Enrollment: 24
Study Start Date: December 2013
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
Single ascending doses of PF-06678552 or placebo to investigate the safety, tolerability, PK, and PD.
Drug: PF-06678552 or Placebo
PF-06678552 or placebo will be administered as an extemporaneously prepared solution once in each period.
Experimental: Cohort 2
Single ascending doses of PF-06678552 or placebo to investigate the safety, tolerability, PK, and PD.
Drug: PF-06678552 or Placebo
PF-06678552 or placebo will be administered as an extemporaneously prepared solution once in each period.
Experimental: Cohort 3
Single ascending doses of PF-06678552 or placebo to investigate the safety, tolerability, PK, and PD.
Drug: PF-06678552 or Placebo
PF-06678552 or placebo will be administered as an extemporaneously prepared solution once in each period.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  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: NCT01992614

Locations
Belgium
Pfizer Investigational Site
Brussels, Belgium, B-1070
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01992614     History of Changes
Other Study ID Numbers: B7611001
Study First Received: November 19, 2013
Last Updated: March 27, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Pfizer:
Single Ascending Dose
healthy subjects
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 21, 2014