This study is to characterize mass balance and further the understanding of human pharmacokinetics, metabolism, and excretion of radiolabeled \[14C\]PF-07321332 in healthy male participants following oral administration with ritonavir.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Single oral dose of 300 mg \[14C\]PF-07321332 containing approximately 100 µCi \[14C\]PF-07321332 coadministered with 100 mg ritonavir.
Cumulative amount of radioactivity Recovered in Urine (Ae)
Ae is the cumulative amount of radioactivity recovered in urine. Cumulative amount was calculated as sum of urine drug concentration in sample volume for each collection interval. Sample volume = (urine weight in gram \[g\]/1.020), where 1.020 g/mL is the approximate specific gravity of urine.
Time frame: 0 to 240 hours
Cumulative amount of radioactivity Recovered in Feces (Ae)
Fe is the cumulative amount of radioactivity recovered in feces. Cumulative amount was calculated as sum of feces drug concentration in sample volume for each collection interval. Sample volume = (feces weight in gram \[g\]).
Time frame: 0 to 240 hours
Metabolic Profiling in blood
Metabolic profiling/identification and determination of relative abundance of \[14C\]PF-07321332 and the metabolites of \[14C\]PF-07321332 in plasma if possible.
Time frame: 0 to 24 hours
Metabolic Profiling in Urine
Metabolic profiling/identification and determination of relative abundance of \[14C\]PF-07321332 and the metabolites of \[14C\]PF-07321332 in urine if possible.
Time frame: 0 to 240 hours
Metabolic Profiling in Feces
Metabolic profiling/identification and determination of relative abundance of \[14C\]PF-07321332 and the metabolites of \[14C\]PF-07321332 in feces if possible.
Time frame: 0 to 240 hours
Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)
Time frame: Baseline (Day 0) up to 28 days after last dose of study medication
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Number of Participants With Notable Electrocardiogram (ECG) Values
Time frame: From baseline up to 11 days.
Number of Participants With Clinically Notable Vital Signs
Time frame: From baseline up to 11 days
Number of Participants With Clinically Notable Clinical Chemistry/Biochemistry Shifts Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade
Time frame: From baseline up to 11 days