A Phase 1 interventional study of [14C]PF-05221304 in Healthy, sponsored by Pfizer. Completed at 1 site in United States. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-12-04.
Sponsored by Pfizer · Phase 1, Interventional, and Basic science
The purpose of the study is to characterize the absorption, distribution, metabolism, and excretion (ADME) of a single oral dose of [14C]PF-05221304 in Healthy Adult Male Subjects
Exclusion Criteria:
\[14C\]PF-05221304
Drug: [14C]PF-05221304
a single oral dose of \[14C\]PF-05221304 (50 mg/100 µCi liquid formulation)
Mass Balance
Cumulative recovery of urinary, fecal, and total excretion of radioactivity over time expressed as percentage of total radioactive dose administered
Time frame: 0-96 hr
Metabolic profiling for PF-05221304 in plasma, urine, and feces
Percent (%) of each radiolabeled drug-related material (parent and each metabolite) will be determined in plasma, urine and feces
Time frame: 0-96 hr
Radioactivity AUClast
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for radioactivity
Time frame: 0-96 hr
Plasma PF-05221304 AUClast
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-05221304
Time frame: 0-96 hr
Radioactivity AUCinf
Area Under the Curve From Time Zero to Extrapolated Infinite Time \[AUC (0- infinity)\] for radioactivity
Time frame: 0-96 hr
Plasma PF-05221304 AUCinf
Area Under the Curve From Time Zero to Extrapolated Infinite Time \[AUC (0- infinity)\] for PF-05221304
Time frame: 0-96 hr
Radioactivity Cmax
Maximum Observed Plasma Concentration (Cmax) for radioactivity
Time frame: 0-96 hr
Plasma PF-05221304 Cmax
Maximum Observed Plasma Concentration (Cmax) for PF-05221304
Time frame: 0-96 hr
Radioactivity Tmax
Time to Reach Maximum Observed Plasma Concentration for radioactivity
Time frame: 0-96 hr
Plasma PF-05221304 Tmax
Time to Reach Maximum Observed Plasma Concentration for PF-05221304
Time frame: 0-96 hr
Radioactivity t1/2
Plasma Decay Half-Life (t1/2) for radioactivity
Time frame: 0-96 hr
Plasma PF-05221304 t1/2
Plasma Decay Half-Life (t1/2) for PF-05221304
Time frame: 0-96 hr
Number of subjects experiencing an adverse event
Assessment by physical examinations, adverse event monitoring, clinical laboratory measurements, vital signs and ECG. 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. Treatment-emergent are events between dosing with study drug and up to 28 days after 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: Up to 28 days post dosing of IP on Day 1
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 2018. You cannot join it, but the record below documents what was studied.
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