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The current study is the second clinical administration with PF-07304814, the phosphate prodrug of the active moiety PF-00835231, and the first in healthy adult participants. It is to evaluate safety, tolerability and PK of single escalating doses of PF 07304814 given as a 24-h IV infusion.
The current study is the second clinical administration with PF-07304814, the phosphate prodrug of the active moiety PF-00835231, and the first in healthy adult participants. It is to evaluate safety, tolerability and PK of single escalating doses of PF 07304814 given as a 24-h IV infusion. This is a randomized, double-blind, sponsor-open, placebo-controlled trial. There will be 2 cohorts with a total of approximately 16 participants planned (approximately 8 participants in each cohort).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | PF-07304814 assignment |
|
| Placebo | Placebo Comparator | Placebo assigned |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-07304814 | Drug | Participants will receive PF-07304814 |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment emergent treatment-related adverse event(s) | Frequency, severity and causal relationship of treatment emergent adverse events (TEAEs) and withdrawals due to TEAEs | Dosing through follow-up call (28-32 days after last dose of investigational product) |
| Number of participants with laboratory test findings of potential clinical importance | Percentage of subjects with laboratory abnormalities | Dosing through Day 5 of last period |
| Number of participants with vital signs findings of potential clinical importance | blood pressure, pulse rate, temperature, respiration rate | Dosing through Day 5 of last period |
| Number of participants with ECG findings of potential clinical importance | Number of subjects with change from baseline in electrocardiogram (ECG) parameters | Dosing through Day 5 of last period |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Cmax of PF-07304814 (prodrug) and PF 00835231 (active moiety) | Maximum plasma concentration | 0-48 hours post the start of dosing |
| Plasma C24 of PF-07304814 (prodrug) and PF 00835231 (active moiety) |
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Inclusion Criteria:
BMI of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Haven Clinical Research Unit | New Haven | Connecticut | 06511 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36285536 | Derived | Zhu T, Pawlak S, Toussi SS, Hackman F, Thompson K, Song W, Salageanu J, Winter E, Shi H, Winton J, Binks M. Safety, Tolerability, and Pharmacokinetics of Intravenous Doses of PF-07304814, a Phosphate Prodrug Protease Inhibitor for the Treatment of SARS-CoV-2, in Healthy Adult Participants. Clin Pharmacol Drug Dev. 2022 Dec;11(12):1382-1393. doi: 10.1002/cpdd.1174. Epub 2022 Oct 26. |
| 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 |
|---|---|
| C000714028 | lufotrelvir |
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| Drug |
Participants will recieve placebo |
|
Plasma concentration at the end of infusion (24 hours post the start of infusion)
| 0-48 hours post the start of dosing |
| Plasma Css of PF-07304814 (prodrug) and PF 00835231 (active moiety) | Plasma steady state concertation | 0-48 hours post the start of dosing |
| Plasma AUClast of PF-07304814 (prodrug) and PF 00835231 (active moiety) | Area under the serum concentration time profile from time zero to the time of the last quantifiable concentration. | 0-48 hours post the start of dosing |
| Plasma AUCinf of PF-07304814 (prodrug) and PF 00835231 (active moiety) | Area under the serum concentration time profile from time zero to infinity. | 0-48 hours post the start of dosing |
| Plasma AUCinf (dn) of PF-07304814 (prodrug) and PF 00835231 (active moiety) | Dose normalized AUCinf | 0-48 hours post the start of dosing |
| Plasma Css (dn) of PF-07304814 (prodrug) and PF 00835231 (active moiety) | Dose normalized Css | 0-48 hours post the start of dosing |
| Plasma t1/2 of PF-07304814 (prodrug) and PF 00835231 (active moiety) | Terminal half life | 0-48 hours post the start of dosing |
| Plasma CL of PF-07304814 (prodrug) | Clearance | 0-48 hours post the start of dosing |
| Plasma Vdss of PF-07304814 (prodrug) | Volume of distribution at steady state | 0-48 hours post the start of dosing |
| PF-00835231 urinary PK: Ae | Amount of unchanged drug excreted in urine over collection interval | 0-36 hours post the start of dosing |
| PF-00835231 urinary PK: Ae% | Percent of dose excreted in urine as unchanged drug over the collection interval. | 0-36 hours post the start of dosing |