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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-507354-32-00 | Registry Identifier | CTIS (EU) |
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Study was terminated early . This decision was not due to any safety concerns associated with PF-07899895 but rather due to a business decision.
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The purposes of the study are as follows:
The study is seeking participants who:
Participants will receive either PF-07899895 or placebo (dummy pill) by chance. In the first part of the study (Part A):
In the second part of the study (Part B):
- each participant will need to take 10 days of dosing and will stay in the study clinic for clinical checks for 13 days.
In the third part of the study (Part C):
The planned duration of participation from screening to follow-up in:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-07899895 | Experimental | Participants will receive single or multiple ascending oral doses of PF-07899895. |
|
| Placebo | Placebo Comparator | Participants will receive matching placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-07899895 | Drug | Participants will receive oral ascending doses. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AE observed after single or multiple doses | number of participants experience AE or SAEs. | Day 1 up to Day 28 (Part A)/Day 1 up to Day 38 (Part B) |
| Laboratory abnormalities following single or multiple ascending doses | number of participants with laboratory abnormalities | Day 1 up to Day 28 (Part A)/Day 1 up to Day 38 (Part B) |
| Vital sign changes following single or multiple ascending doses | Number of participants with change from baseline in vital signs | Day 1 up to Day 28 (Part A)/Day 1 up to Day 38 (Part B) |
| ECG changes following single or multiple ascending doses | Number of participants with change from baseline in electrocardiogram (ECG) parameters | Day 1 up to Day 28 (Part A)/Day 1 up to Day 38 (Part B) |
| Changes in physical examination after single or multiple ascending doses | Number of participants with change from baseline in physical examinations (PE) | Day 1 up to Day 28 (Part A)/Day 1 up to Day 38 (Part B) |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast) | descriptive summary of AUClast by treatment | Day 1 up to Day 3 (Part A) |
| Dose normalized AUClast divided by dose (AUClast(dn)) |
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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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| Placebo |
| Drug |
Participants will receive matching placebo. |
|
descriptive summary of AUClast by treatment
| Day 1 up to Day 3 (Part A) |
| Maximum Observed Plasma Concentration (Cmax) | descriptive summary of Cmax by treatment | Day 1 (Part A)/Day 1 and Day 10 (Part B) |
| Dose normalized Cmax divided by dose (Cmax(dn)) | descriptive summary of Cmax,dn by treatment | Day 1 (Part A)/Day 1 and Day 10 (Part B) |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | descriptive summary of Tmax by treatment | Day 1 (Part A)/Day 1 and Day 10 (Part B) |
| Area under the concentration time-profile from time 0 extrapolated to infinity (AUCinf) | descriptive summary of AUCinf by treatment | Day 1 up to Day 3 (Part A) |
| Dose normalized AUCinf divided by dose (AUCinf(dn)) | descriptive summary of AUCinf,dn by treatment | Day 1 up to Day 3 (Part A) |
| Plasma elimination half-life is the time measured for the plasma concentration to decrease by one half (t½) | descriptive summary of t1/2 by treatment | Day 1 up to Day 3 (Part A)/Day 10 up to Day 12 (Part B) |
| Apparent clearance (CL/F) | descriptive summary of CL/F by treatment | Day 1 up to Day 3 (Part A)/Day 10 up to Day 12 (Part B) |
| Apparent volume of distribution after oral dose is influenced by the fraction absorbed (Vz/F) | descriptive summary of Vz/F | Day 1 up to Day 3 (Part A)/Day 10 up to Day 12 (Part B) |
| Area under the concentration-time curve from time 0 to time tau, where tau=24 hrs (AUCtau) | descriptive summary of AUCtau | Day 1 and Day 12 (Part B) |
| Dose normalized AUCtau divided by dose (AUCtau(dn)) | descriptive summary of AUCtau,dn | Day 1 and Day 12 (Part B) |
| Observed accumulation ratio for Rac for AUC | descriptive summary of observed Rac for AUC | Day 1 and Day 12 (Part B) |
| Observed accumulation ratio for Cmax (Rac,Cmax) | descriptive summary of Rac,Cmax | Day 1 and Day 12 (Part B) |