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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-509339-17-00 | Registry Identifier | CTIS (EU) |
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The purpose of this clinical study is to learn about the safety and effects of the study medicine (PF-07054894) in healthy Japanese participants.
The study is seeking the following participants:
In research, the participants in clinical studies are assigned by chance to separate groups that are given different treatments. Hence participants will be by chance assigned to receive either PF-07054894 or a harmless treatment that has no medical effect (placebo). Both these will be taken by mouth for 14 days. The total duration of the study is about 11 weeks, with a follow-up via telephone about 6 weeks after first treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-07054894 | Experimental |
| |
| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-07054894 or placebo | Drug | multiple oral doses of PF-07054894 for 14 days |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AE) or serious adverse events (SAE) | An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) is defined as any untoward medical occurrence at any dose that results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; results in congenital anomaly/birth defect. AEs include both SAEs and AEs. | Screening, Baseline through study completion, an average of 11 weeks |
| Number of participants with clinically meaningful change from baseline in laboratory tests results | Screening, Baseline, Day 2, 7 and 14 | |
| Number of participants with clinically meaningful change from baseline in vital signs | Number of participants with change from baseline in vital signs including supine blood pressure and pulse rate | Screening, Day 1, 2, 7, 14, and 15 |
| Number of participants with clinically meaningful change from baseline in electrocardiogram (ECG) parameters | Screening, Day 1, 2, 7, 14 and 15 | |
| Maximal plasma concentration (Cmax) | The maximum observed plasma concentration (Cmax) will be observed directly from data. | Day 1 and 14 |
| Time to Maximum Plasma Concentration (Tmax) | Tmax will be observed directly from data | Day 1 and 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Observed Accumulation Ratio (Rac) | Rac is calculated as, area under the curve from time zero to end of dosing interval on Day 14 (AUCtau) divided by area under the curve from time zero to end of dosing interval on Day 1 (AUCτ) | Day 14 |
| Observed Accumulation Ratio Based on Cmax (Rac,Cmax) |
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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 |
|---|---|---|---|---|---|---|
| Pfizer Clinical Research Unit - Brussels | 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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| Area Under the Plasma Concentration-Time Profile From Time Zero (AUCτ) To End of Dosing Interval (AUCt) |
AUCτ is summarized by dosing interval and day. Dosing interval is the interval τ between administration of doses of drug. |
| Day 1 and 14 |
| Half-life of PF-07054894 | terminal elimination half-life will be calculated based on the measured data | Day 14 |
Rac Cmax is calculated as, maximum observed plasma concentration on Day 14 (Cmax) divided by maximum observed plasma concentration on Day 1 (Cmax) |
| Day 14 |
| Trough plasma concentrations (Ctrough) | Day 14 |
| Apparent Volume of Distribution (Vz/F) as data permits | Vz/F is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. VZ/F after oral dose is influenced by the fraction absorbed. | Day 14 |
| Apparent Oral Clearance (CL/F) | CL/F is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes | Day 14 |