PF-06427878 is a new compound proposed for the treatment of hyperlipidemia. The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single oral doses of PF-06427878 in healthy adult subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
16
PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.
PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.
PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.
New Haven Clinical Research Unit
New Haven, Connecticut, United States
Assessment of adverse events (AEs).
Time frame: 0-48 h post dose
Assessment of clinical laboratory tests.
Time frame: 0-48 h post dose
Assessment of vital signs (including blood pressure and pulse rate).
Time frame: 0-48 h post dose
Assessment of cardiac conduction intervals as assessed via 12-lead electrocardiogram (ECG).
Time frame: 0-48 h post dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06427878
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)] for PF-06427878
AUC (0 - inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf).
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose
Maximum Observed Plasma Concentration (Cmax) for PF-06427878
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose
Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose
Apparent Oral Clearance (CL/F) for PF-06427878
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PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.
PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.
PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.
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.
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose
Apparent Volume of Distribution (Vz/F) for PF-06427878
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, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose
Plasma Decay Half-Life (t1/2) for PF-06427878
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 48 hours post dose