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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-000772-38 | EudraCT Number |
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The purpose of the study is to evaluate the safety, tolerability, and PK of single escalating doses and multiple escalating doses of PF-07054894.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-07054894 | Experimental | Participants will receive single or multiple ascending doses of oral PF-07054894 |
|
| Placebo | Placebo Comparator | Participants will receive matching placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-07054894 | Drug | Participants will receive oral ascending doses |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AEs following Single ascending dose (SAD) | Frequency, severity and causal relationship of treatment emergent adverse events (TEAEs) and withdrawals due to TEAEs | Day 1 up to Day 28 (SAD) |
| AEs following multiple ascending dose (MAD) | Frequency, severity and causal relationship of treatment emergent adverse events (TEAEs) and withdrawals due to TEAEs | Day 1 up to Day 42 (MAD) |
| Percentage of subjects with laboratory abnormalities | Day 1 up to Day 7 (SAD) or Day 1 up to Day 21 (MAD) | |
| Number of subjects with change from baseline in vital signs | Number of subjects with change from baseline of blood pressure, pulse rate, and oral temperature | Day 1 up to Day 7 (SAD) or Day 1 up to Day 21 (MAD) |
| Number of subjects with change from baseline in electrocardiogram (ECG) parameters | Day 1 up to Day 7 (SAD) or Day 1 up to Day 21 (MAD) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma concentration (Cmax) | Maximum observed plasma concentration (Cmax) | Day 1 (SAD) or Day 1 and Day 14 (MAD) |
| Time to reach plasma Cmax (Tmax) | Time to reach maximum observed plasma concentration (Tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brussels Clinical Research Unit | Brussels | Bruxelles-capitale, Région de | B-1070 | Belgium |
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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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| Placebo |
| Drug |
Participants will receive matching placebo |
|
| Day 1 (SAD) or Day 1 and Day 14 (MAD) |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) | Day 1 up to Day 3 (SAD) |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] | AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). | Day 1 up to Day 3 (SAD) |
| Dose normalized Cmax (Cmax(dn)) | Dose normalized maximum plasma concentration (Cmax(dn)) | Day 1 (SAD) or Day 1 and Day 14 (MAD) |
| Apparent Oral Clearance (CL/F) | Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed and a quantitative measure of the rate at which the drug is removed from the blood. | Day 1 (SAD) or Day 14 (MAD) |
| Apparent Volume of Distribution (Vz/F) | Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed. | Day 1 (SAD) or Day 14 (MAD) |
| Single dose and Multiple Dose PK half-life (t½) | Plasma elimination half-life is the time measured for the plasma concentration to decrease by one half. | Day 1 (SAD) or Day 14 (MAD) |
| Observed Accumulation Ratio for Cmax (Rac,Cmax) | Accumulation ratio based on maximum plasma concentration (Cmax) calculated as: Rac,Cmax = Cmax at steady state (ss) divided by Cmax at first dose. | MAD, Day 14 |
| Observed Accumulation Ratio for AUCτau (Rac, AUCτau) | Accumulation ratio calculated as, Rac obtained from Area Under the Concentration Time Curve (AUCτau) from time 0-τau (Day 14) divided by AUC from time 0-τau (Day 1). | MAD, Day 14 |
| Area Under the Curve From Time Zero to End of Dosing Interval (AUCτau) | Area under the concentration curve from time 0 to end of dosing interval (AUCτau), where dosing interval is 12 hours. | Day 1 and Day 14 of MAD |
| Minimum Observed Plasma Trough Concentration (Cmin) | Minimum plasma concentration over the dosing interval τau (12 hour) from first dose to last dose | Day 1 up to Day 14 of MAD |
| Multiple dose PK/AUCτau (dn) | Dose normalized area under the curve over the dosing interval τau (12 hour) after the first and last dose (AUCτau (dn)) | Day 1 and Day 14 of MAD |
| Cumulative Amount of Drug Recovered Unchanged in Urine during dosing interval (Ae,τau) | Cumulative amount of drug recovered unchanged in urine during the dosing interval, where the dosing interval is 12 hours (Ae,τau) | MAD, Day 14 |
| Percentage of Dose Recovered Unchanged in Urine From Time 0 to the Dosing Interval τau (Ae,τau%) | Percent of dose recovered in urine as unchanged drug over the dosing interval (Ae,τau%) | MAD, Day 14 |
| Renal Clearance (Clr) | Renal clearance calculated as cumulative amount of drug recovered unchanged in urine during the dosing interval (Ae,τau) divided by area under the plasma concentration time-curve from time zero to end of dosing interval (AUCτau), where dosing interval is 12 hours. | MAD, Day 14 |