A Phase 1 interventional study of PF-04965842 and Absolute Bioavailability in Healthy, sponsored by Pfizer. Completed at 2 sites in Netherlands. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-12-21.
Sponsored by Pfizer · Phase 1, Interventional, and Other
This study will investigate the absorption, metabolism and excretion of 14C-PF 04965842 and characterize plasma, fecal and urinary radioactivity and identify any metabolites, if possible, of 14C PF-04965842 in humans. In addition, this study will provide a better understanding of the pharmacokinetic disposition of PF-04965842 by obtaining intravenous (IV) clearance and delineating the extent of oral absorption (absolute bioavailability (F) and fraction absorbed (Fa)).
Exclusion Criteria
Subjects with any of the following characteristics/conditions will not be included in the study:
Subjects with ANY of the following abnormalities in clinical laboratory tests at Screening, as assessed by the study specific laboratory and confirmed by a single repeat, if deemed necessary:
Cumulative recovery of radioactivity in urine and feces
Drug: PF-04965842
Oral absolute bioavailability
Drug: Absolute Bioavailability
14C labeled PF-04965842
Oral dose of unlabeled PF-04965842 and an IV dose of 14C labeled PF- 04965842
Cumulative recovery of radioactivity
Total radioactivity in urine and feces based on total administered dose.
Time frame: From predose to Day 14 day
Cmax
Maximum plasma concentration
Time frame: From predose to Day 5
Tmax
Time to maximum concentration
Time frame: From predose to Day 5
AUClast
Area under the plasma concentration-time curve from time 0 to last quantifiable concentration
Time frame: From predose to Day 5
AUCinf
Area under the plasma concentration-time curve from time zero to infinity
Time frame: From predose to Day 5
t1/2
Apparent terminal elimination half-life
Time frame: From predose to Day 5
CL/F
Apparent total body clearance
Time frame: From predose to Day 5
Vz/F
Apparent volume of distribution
Time frame: From predose to Day 5
Vss (IV)
Steady State Volume of distribution
Time frame: From predose to Day 5
CL (IV)
Total Body Clearance
Time frame: From predose to Day 5
F
Absolute bioavailability= ratio of the adjusted geometric means of dose normalized AUCinf for unlabeled PF-04965842 and IV labeled 14C-PF-04965842
Time frame: From predose to Day 5
Fa
Fraction of PF 04965842 dose absorbed = Total 14C urine data following both IV and oral administration of 14C PF 04965842 (quantification by AMS).
Time frame: Predose to Day Day 5
Plan to share: No — Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests
This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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