A Phase 1 interventional study of PF-06427878 and Placebo in Healthy, sponsored by Pfizer. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-03-04.
Sponsored by Pfizer · Phase 1, Interventional, and Basic science
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.
Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
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Exclusion Criteria:
Single ascending doses of PF-06427878 or placebo to investigate the safety, tolerability, and PK.
Drug: PF-06427878 · Drug: Placebo
Single ascending doses of PF-06427878 or placebo to investigate the safety, tolerability, and PK.
Drug: PF-06427878 · Drug: Placebo
Single ascending doses of PF-06427878 or placebo to investigate the safety, tolerability, and PK.
Drug: PF-06427878 · Drug: Placebo
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.
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.
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
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
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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