Healthy
Conditions
Brief summary
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
Interventions
DRUG[14C]PF-05221304
a single oral dose of \[14C\]PF-05221304 (50 mg/100 µCi liquid formulation)
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Ages of 18 and 45 years, inclusive. 2. Body mass index (BMI) of \>= 17.5 and \<= 30.4 kg/m2 3. Total body weight \> 50 kg (110 lb).
Exclusion criteria
1\. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, allergic disease or clinical findings.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mass Balance | 0-96 hr | Cumulative recovery of urinary, fecal, and total excretion of radioactivity over time expressed as percentage of total radioactive dose administered |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radioactivity AUClast | 0-96 hr | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for radioactivity |
| Plasma PF-05221304 AUClast | 0-96 hr | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-05221304 |
| Radioactivity AUCinf | 0-96 hr | Area Under the Curve From Time Zero to Extrapolated Infinite Time \[AUC (0- infinity)\] for radioactivity |
| Plasma PF-05221304 AUCinf | 0-96 hr | Area Under the Curve From Time Zero to Extrapolated Infinite Time \[AUC (0- infinity)\] for PF-05221304 |
| Radioactivity Cmax | 0-96 hr | Maximum Observed Plasma Concentration (Cmax) for radioactivity |
| Metabolic profiling for PF-05221304 in plasma, urine, and feces | 0-96 hr | Percent (%) of each radiolabeled drug-related material (parent and each metabolite) will be determined in plasma, urine and feces |
| Radioactivity Tmax | 0-96 hr | Time to Reach Maximum Observed Plasma Concentration for radioactivity |
| Plasma PF-05221304 Tmax | 0-96 hr | Time to Reach Maximum Observed Plasma Concentration for PF-05221304 |
| Radioactivity t1/2 | 0-96 hr | Plasma Decay Half-Life (t1/2) for radioactivity |
| Plasma PF-05221304 t1/2 | 0-96 hr | Plasma Decay Half-Life (t1/2) for PF-05221304 |
| Number of subjects experiencing an adverse event | Up to 28 days post dosing of IP on Day 1 | 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. |
| Plasma PF-05221304 Cmax | 0-96 hr | Maximum Observed Plasma Concentration (Cmax) for PF-05221304 |
Countries
United States
Outcome results
None listed