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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
24
PF-06678552 or placebo will be administered as an extemporaneously prepared solution once in each period.
PF-06678552 or placebo will be administered as an extemporaneously prepared solution once in each period.
PF-06678552 or placebo will be administered as an extemporaneously prepared solution once in each period.
Pfizer Investigational Site
Brussels, Belgium
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
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06678552
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Time frame: 0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - infinity)] for PF-06678552
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).
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) for for PF-06678552
Maximum Observed Plasma Concentration (Cmax)
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) for PF-06678552
Time to Reach Maximum Observed Plasma Concentration (Tmax)
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) for PF-06678552
Plasma Decay Half-Life (t1/2)
Time frame: 0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Apparent Oral Clearance (CL/F) for PF-06678552
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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.
Time frame: 0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Apparent Volume of Distribution (Vz/F) for PF-06678552
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.
Time frame: 0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06644927
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Time frame: 0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - infinity)] for PF-06644927
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).
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) for PF-06644927
Maximum Observed Plasma Concentration (Cmax)
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) for PF-06644927
Time to Reach Maximum Observed Plasma Concentration (Tmax)
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) for PF-06644927
Plasma Decay Half-Life (t1/2)
Time frame: 0, 0.5, 1, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose
Amount of PF-06644927 excreted in the urine (Ae)
Amount of drug excreted in the urine is a measure of the degree that the kidneys filter drug from the blood to the urine.
Time frame: 0-4, 4-12, and 12-24 hours post dose
Percent of PF-06678552 dose excreted in the urine as PF-06644927 (Ae%)
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.
Time frame: 0-4, 4-12, and 12-24 hours post dose
Renal Clearance (CLr) for PF-06644927
Renal clearance is the measure of the rate of drug moving into the urine from blood
Time frame: 0-4, 4-12, and 12-24 hours post dose