The current study is the first clinical trial proposed with PF-06815345. It is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) following administration of single oral doses of PF-06815345 to healthy adult subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
25
PF-06815345 will be administered as a liquid dosage formulation
Placebo
PF-06815345 will be administered as either solid dosage formulation or liquid dosage formulation
Pfizer Clinical Research Unit
Brussels, Belgium
Number of Subjects With Treatment Emergent Treatment-Related Adverse Events (AEs)
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.
Time frame: Baseline (Day 0) up to 28 days after last dose of study medication
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06815345
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, 10, 14, 24, and 48 hours post dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0- infinity)] for PF-06815345
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, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Maximum Observed Plasma Concentration (Cmax) for PF-06815345
Maximum Observed Plasma Concentration (Cmax)
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Time to Reach Maximum Observed Concentration for PF-06815345
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Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Plasma Decay Half-Life (t1/2) for PF-06815345
Plasma Decay Half-Life (t1/2)
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Apparent Oral Clearance (CL/F) for PF-06815345
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, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Apparent Volume of Distribution (Vz/F) for PF-06815345
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, 10, 14, 24, and 48 hours post dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for the metabolite (PF-06811701)
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, 10, 14, 24, and 48 hours post dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0- infinity)] for metabolite (PF-06811701)
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, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Maximum Observed Plasma Concentration (Cmax) for metabolite (PF-06811701)
Maximum Observed Plasma Concentration (Cmax)
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Time to Reach Maximum Observed Concentration for metabolite (PF-06811701)
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose
Plasma Decay Half-Life (t1/2) for metabolite (PF-06811701)
Plasma Decay Half-Life (t1/2)
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 10, 14, 24, and 48 hours post dose