A Multiple Dose Study Of PF-06678552 In Healthy Subjects

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT02079922
First received: March 4, 2014
Last updated: July 16, 2014
Last verified: July 2014

March 4, 2014
July 16, 2014
March 2014
July 2014   (final data collection date for primary outcome measure)
Assessment of adverse events (AEs), clinical laboratory tests, vital signs (including blood pressure and pulse rate), and cardiac conduction intervals as assessed by 12 lead ECG. [ Time Frame: 0 to 24 days post dose ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT02079922 on ClinicalTrials.gov Archive Site
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06644927 on day 1 [ Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose ] [ Designated as safety issue: No ]
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06644927 on day 7 [ Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose ] [ Designated as safety issue: No ]
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06644927 on day 14 [ Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose ] [ Designated as safety issue: No ]
  • Area Under the Curve during the dosing interval (AUCtau) for PF-06644927 on day 1 [ Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose ] [ Designated as safety issue: No ]
  • Area Under the Curve during the dosing interval (AUCtau) for PF-06644927 on day 7 [ Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose ] [ Designated as safety issue: No ]
  • Area Under the Curve during the dosing interval (AUCtau) for PF-06644927 on day 14 [ Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose ] [ Designated as safety issue: No ]
  • Maximum Observed Plasma Concentration (Cmax) for PF-06644927 on day 1 [ Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose ] [ Designated as safety issue: No ]
  • Maximum Observed Plasma Concentration (Cmax) for PF-06644927 on day 7 [ Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose ] [ Designated as safety issue: No ]
  • Maximum Observed Plasma Concentration (Cmax) for PF-06644927 on day 14 [ Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose ] [ Designated as safety issue: No ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06644927 on day 1 [ Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose ] [ Designated as safety issue: No ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06644927 on day 7 [ Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose ] [ Designated as safety issue: No ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06644927 on day 14 [ Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose ] [ Designated as safety issue: No ]
  • Plasma Decay Half-Life (t1/2) for PF-06644927 on day 14 [ Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48 hours post dose ] [ Designated as safety issue: No ]
  • Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06644927 on day 7 relative to day 1 [ Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose ] [ Designated as safety issue: No ]
  • Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06644927 on day 14 relative to day 1 [ Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose ] [ Designated as safety issue: No ]
  • Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUC)) for PF-06644927 on day 7 relative to day 1 [ Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose ] [ Designated as safety issue: No ]
  • Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUC)) for PF-06644927 on day 14 relative to day 1 [ Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose ] [ Designated as safety issue: No ]
  • Amount of PF-06644927 excreted in urine (Ae) on day 14 [ Time Frame: 0-12 hours post dose ] [ Designated as safety issue: No ]
  • Percent of dose excreted in urine as PF-06644927 (Ae%) on day 14 [ Time Frame: 0-12 hours post dose ] [ Designated as safety issue: No ]
  • Renal clearance of PF-06644927 (CLr) on day 14 [ Time Frame: 0-12 hours post dose ] [ Designated as safety issue: No ]
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06678552 on day 1 [ Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose ] [ Designated as safety issue: No ]
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06678552 on day 7 [ Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose ] [ Designated as safety issue: No ]
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06678552 on day 14 [ Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose ] [ Designated as safety issue: No ]
  • Area Under the Curve during the dosing interval (AUCtau) for PF-06678552 on day 1 [ Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose ] [ Designated as safety issue: No ]
  • Area Under the Curve during the dosing interval (AUCtau) for PF-06678552 on day 7 [ Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose ] [ Designated as safety issue: No ]
  • Area Under the Curve during the dosing interval (AUCtau) for PF-06678552 on day 14 [ Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose ] [ Designated as safety issue: No ]
  • Maximum Observed Plasma Concentration (Cmax) for PF-06678552 on day 1 [ Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose ] [ Designated as safety issue: No ]
  • Maximum Observed Plasma Concentration (Cmax) for PF-06678552 on day 7 [ Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose ] [ Designated as safety issue: No ]
  • Maximum Observed Plasma Concentration (Cmax) for PF-06678552 on day 14 [ Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose ] [ Designated as safety issue: No ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06678552 on day 1 [ Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose ] [ Designated as safety issue: No ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06678552 on day 7 [ Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose ] [ Designated as safety issue: No ]
  • Plasma Decay Half-Life (t1/2) for PF-06678552 on day 14 [ Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12, 16, 24, 48 hours post dose ] [ Designated as safety issue: No ]
  • Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06678552 on day 7 relative to day 1 [ Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose ] [ Designated as safety issue: No ]
  • Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06678552 on day 14 relative to day 1 [ Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose ] [ Designated as safety issue: No ]
  • Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUC)) for PF-06678552 on day 7 relative to day 1 [ Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose ] [ Designated as safety issue: No ]
  • Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUC)) for PF-06678552 on day 14 relative to day 1 [ Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 hours post dose ] [ Designated as safety issue: No ]
  • Apparent Oral Clearance (CL/F) of PF-06678552 on day 7 [ Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 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. 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 Oral Clearance (CL/F) of PF-06678552 on day 14 [ Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 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. 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) of PF-06678552 on day 7 [ Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 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.
  • Apparent Volume of Distribution (Vz/F) of PF-06678552 on day 14 [ Time Frame: 0, 0.25, 0.5, 1, 2, 3, 4, 8, 12 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.
Same as current
Not Provided
Not Provided
 
A Multiple Dose Study Of PF-06678552 In Healthy Subjects
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study To Assess The Safety, Tolerability, And Pharmacokinetics Of PF-06678552 After Administration Of Multiple Escalating Oral Doses In Healthy Adult Subjects

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 multiple oral doses of PF-06678552 in healthy subjects.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
Healthy
  • Drug: PF-06678552
    PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
  • Drug: Placebo
    PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
  • Drug: PF-06678552
    PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.
  • Drug: Placebo
    PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.
  • Experimental: Cohort 1
    Single dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
    Interventions:
    • Drug: PF-06678552
    • Drug: Placebo
  • Experimental: Cohort 2
    Single dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
    Interventions:
    • Drug: PF-06678552
    • Drug: Placebo
  • Experimental: Cohort 3
    Single dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
    Interventions:
    • Drug: PF-06678552
    • Drug: Placebo
  • Experimental: Cohort 4
    Single dose level of PF-06678552 or placebo every 12 hours (Q12H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
    Interventions:
    • Drug: PF-06678552
    • Drug: Placebo
  • Experimental: Cohort 5
    Single dose level of PF-06678552 or placebo will be provided either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
    Interventions:
    • Drug: PF-06678552
    • Drug: Placebo
  • Experimental: Cohort 6
    Single dose level of PF-06678552 or placebo will be provided either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days to investigate the safety, tolerability, and pharmacokinetics.
    Interventions:
    • Drug: PF-06678552
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
74
July 2014
July 2014   (final data collection date for primary outcome measure)

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)
Both
18 Years to 55 Years
Yes
Contact: Pfizer CT.gov Call Center 1-800-718-1021
Belgium
 
NCT02079922
B7611002
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2014

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