[14C]PF-06882961, 50 mg
DrugA single oral dose of [14C]PF-06882961, will be administered as a liquid formulation.
NCT Number: NCT04495140
This study is a Phase 1, open-label, non-randomized, 2-period, fixed sequence study to characterize the metabolic profile and routes of excretion of oral [14C]PF-06882961 and to evaluate the absolute oral bioavailability of PF-06882961 and fraction absorbed of [14C]PF-06882961 in reference to intravenous [14C]PF-06882961 in healthy male participants.
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Notify Me18 year–54 year
Male
Interventional
Phase 1
PRA Health Sciences, Groningen, Netherlands
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A single oral dose of [14C]PF-06882961, will be administered as a liquid formulation.
A single, oral, unlabeled dose of PF-06882961, 50 mg will be administered as a liquid formulation. Approximately 3 hours after the administration of the unlabeled oral dose, a single dose of [14C]PF-06882961 will be administered via intravenous infusion.
Time frame: Baseline through approximately hour 312 (day 14). Period 1 is 14 days
Total recovery of radioactivity in urine and feces, and both routes combined, expressed as a percent of total oral radioactive dose administered.
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96-312 hour (hr)
Metabolic profiling/identification and determination of relative abundance of [14C]PF-06882961 and the metabolites of [14C]PF-06882961 in plasma, urine, and feces.
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr
Maximum Observed Plasma Radioactivity
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr
Time to Reach Maximum Observed Plasma Radioactivity
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr
Area under the plasma radioactivity-time profile from time 0 to time of the last quantifiable concentration (Clast)
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr
AUCinf is the area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf).
Time frame: 00, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr
Plasma elimination half-life is the time measured for the plasma radioactivity to decrease by one half.
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr
Maximum Observed Plasma Concentration
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr
Time to Reach Maximum Observed Plasma Concentration
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr
Area under the plasma concentration-time profile from time 0 to time of the last quantifiable concentration (Clast)
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr
AUCinf is Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf).
Time frame: 0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72 hr
where MRT is the Mean Residence Time
Time frame: 0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72 hr
Systemic clearance, CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Time frame: 0, 1, 2, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72 hr
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 blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr
Absolute oral bioavailability following administration of a single oral dose of PF-06882961 in reference to a single intravenous dose of [14C]PF-06882961
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96-312hr
Fraction absorbed calculated from ratio of total urinary radioactivity following oral administration in reference to intravenous administration
Time frame: Baseline in Period 1 up to 32 days after the period 2 doses, for a total of approximately 46 days
adverse events
Time frame: 00, 0.5, 1, 2, 3, 4, 6, 9, 12, 16, 24, 36, 48, 72, 96 hr
Plasma elimination half-life is the time measured for the plasma radioactivity to decrease by one half.
Time frame: baseline, day 5-14 of period 1 (period 1 is 14 days), day 3-8 of period 2 (period 2 is 8 days)
lab tests
Time frame: baseline, day 5-14 of period 1 (period 1 is 14 days), day 3-8 of period 2 (period 2 is 8 days)
ECGs
Time frame: baseline, day 5-14 of period 1 (period 1 is 14 days), day 3-8 of period 2 (period 2 is 8 days)
vitals
Pfizer
Industry
A PHASE 1, OPEN-LABEL, FIXED SEQUENCE, 2-PERIOD STUDY IN HEALTHY ADULT MALE PARTICIPANTS TO ASSESS THE MASS BALANCE, ABSOLUTE BIOAVAILABILITY, FRACTION ABSORBED, AND PHARMACOKINETICS OF [14C]PF-06882961
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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