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The purpose of this study is to learn how a certain amount of [14C] PF-07320948 is taken up into the bloodstream and removed from the body.
This study is seeking participants who are:
This is a 2 Part, 4 Period study where Part 1 has Periods 1 and 2 and Part 2, which is optional, has Periods 3 and 4.
Part 1
Part 2 (Optional)
During study clinic stays and study visits, the study team will collect urine and blood samples and perform safety reviews. If only Part 1 is conducted, total time in the study (screening (start) through follow-up (end)) will be about 14 weeks. If both Part 1 and Part 2 are conducted, total time in the study will be about 22 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Period 1/Treatment A | Experimental | Participants will receive a single oral dose of [14C]PF-07328948 administered as an extemporaneously prepared oral suspension. |
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| Period 2/Treatment B | Experimental | Participants will receive a single tablet of unlabeled oral dose of PF-07328948; ~ 3 hours post-dose, participants will receive a single IV infusion of [14C]PF-07328948 |
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| Period 3/Treatment C | Experimental | Participants will receive unlabeled tablet oral doses of PF-07328948 once daily for 9 days up to 1 month |
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| Period 4/Treatment D | Experimental | Participants will receive a single oral dose of [14C]PF-07328948 administered as an extemporaneously prepared oral suspension on Day 1; From Day 2 until the last day with mass balance assessment, participants will receive once-daily oral doses of unlabeled PF-07328948 tablets |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral [14C]PF-07328948 | Drug | A single oral dose of [14C]PF-07328948 administered as an extemporaneously prepared oral suspension in Period 1 and in Period 4 (optional) |
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| Measure | Description | Time Frame |
|---|---|---|
| Total recovery of radioactivity in urine, feces, expired air (if analyzed and if reportable), and emesis (if any), and all routes combined, expressed as a percentage of oral radioactive dose administered. | Period 1 pre-dose to maximum Days 22 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment Emergent Adverse Events | From baseline and through 28 to 35 days post last study intervention dose |
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Inclusion Criteria
Exclusion Criteria
This study is seeking participants who are:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pfizer CT.gov Call Center | Contact | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fortrea Clinical Research Unit Inc. | Recruiting | Madison | Wisconsin | 53704 | United States |
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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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| Oral Unlabeled PF-07328948 | Drug | A single unlabeled oral dose of PF-07328948 administered as a tablet. Approximately 3 hours post-dose, participants will receive a single IV infusion of [14C]PF-07328948 Period 2: single dose, Period 3: QD Period 4: (Day 2 - mass balance completion) |
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| IV [14C]PF-07328948 | Drug | A single oral dose of [14C]PF-07328948 administered as an extemporaneously prepared oral suspension on Day 1; From Day 2 until the last day with mass balance assessment, participants will receive once-daily oral doses of unlabeled PF-07328948 administered as tablets. |
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