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Based on various healthy authorities feedback on PAXLOVID submission, this study is no longer required.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]PF-07321332 | Experimental | Single oral dose of 300 mg [14C]PF-07321332 containing approximately 100 µCi [14C]PF-07321332 coadministered with 100 mg ritonavir. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]PF-07321332 | Drug | Single oral dose of 300 mg [14C]PF-07321332 containing approximately 100 µCi [14C]PF-07321332 coadministered with 100 mg ritonavir. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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]). | 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. | 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. | 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. | 0 to 240 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) | Baseline (Day 0) up to 28 days after last dose of study medication | |
| Number of Participants With Notable Electrocardiogram (ECG) Values | From baseline up to 11 days. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Number of Participants With Clinically Notable Vital Signs | 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 | From baseline up to 11 days |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |