Single Dose of PF-06835919 Escalation Study in Healthy Adult Subjects

Placebo Comparator: Plasebo

Muut: Placebo

Single or repeated, escalating dose

Kokeellinen: PF-06835919

Lääke: PF-06835919

Single or repeated, escalating dose

Number of Subjects experiencing an Adverse Event

Assessment by adverse event monitoring, 12 lead ECGs, telemetry, vital signs and clinical safety laboratory measurements. Treatment-related AE was any untoward medical occurrence attributed to study drug in a subject who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to Drug was assessed by the investigator (Yes/No). Subjects with multiple occurrences of an AE within a category were counted once within the category.

Maximum Observed Plasma Concentration (Cmax) for PF-06835919

Time to Reach Maximum Observed Concentration for PF-06835919

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06835919

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0- infinity)] for PF-06835919

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).

Plasma Decay Half-Life (t1/2) for PF-06835919 (as permitted)

Plasma Decay Half-Life (t1/2)

Apparent Total Body Clearance (CL/F) for PF-06835919 (as permitted)

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 apparent total body 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) for PF-06835919 (as permitted)

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.