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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-513467-47-00 | Registry Identifier | CTIS (EU) |
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The purpose of the study is to evaluate the safety, tolerability, and Pharmacokinetics (Pharmacokinetics [PK] to better understand how the drug is changed and eliminated from your body after you take it) of single ascending oral doses of PF-07940369 in healthy adult participants.
This study is seeking participants who:
All participants will receive up to 4 single doses of PF-07940369 and up to 2 placebo doses. All treatments will be taken by mouth.
All participants will remain in the study clinic for 4 days for each treatment, for safety review, laboratory collections, and to collect samples for PK.
All participants selected in the study will be required to go through a screening period up to 28 days. A screening period is the time during which a few participants are examined to see whether they are fit for the study. During this period, the participant's medical history and past and current medications will be reviewed. A series of tests will also be performed to see if they are good to be selected for the study. If the participant meets all required criteria and are interested in continuing, the participant will be brought into the study clinic to stay overnight for 4 days for each treatment period. On day 4, the participant will be discharged. About 28 to 35 days after discharge following the final treatment, the participant will be contacted for a follow up visit either in person or by telephone. This is to check up on how the participant is doing and to conclude the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-07940369 and Placebo (Cohort 1) | Experimental | Single dose administration of PF-07940369 and placebo; Within a cohort, participants will receive up to 4 oral doses of PF-07940369 and up to 2 doses of placebo. |
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| PF-07940369 and Placebo (Cohort 2) | Placebo Comparator | Single dose administration of PF-07940369 and placebo; Within a cohort, participants will receive up to 4 oral doses of PF-07940369 and up to 2 doses of placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-07940369 | Drug | Bulk powder for extemporaneous preparation for oral solutions. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) | Baseline (Day 0) up to 35 days after last dose of study medication | |
| Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities | Baseline up to Day 4 | |
| Number of Participants With Clinically Significant Change From Baseline in Vital Signs | Baseline up to Day 4 | |
| Number of Participants With Clinically Significant Change From Baseline in Telemetry Findings | Baseline up to Day 4 | |
| Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Findings | Baseline up to Day 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast) of PF-07940369 | Hour 0, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 24, 36, 48, and 72 post-dose in each period | |
| Maximum Observed Plasma Concentration (Cmax) of PF-07940369 |
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Inclusion Criteria:
Participants are eligible to be included in the study only if all of the following criteria apply:
-Male participants and female participants who are not of childbearing potential who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, blood pressure, pulse rate and standard 12 lead ECG.
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
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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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randomized, double-blinded (investigator- and participant-blinded), sponsor-open, placebo-controlled, 4-period, crossover, interleaving, first in human single ascending oral dose
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Participants will be assigned to receive study intervention according to the assigned treatment group from the randomization scheme. Investigators will remain blinded to each participant's assigned study intervention throughout the course of the study. In order to maintain this blind, an otherwise uninvolved third party will be responsible for the preparation and dispensing of all study intervention and will endeavor to ensure that there are no differences in time taken to dispense or visual presentation, following randomization or dispensing. This third party will instruct the participant to avoid discussing the taste, dosing frequency, or packaging of the study intervention with the investigator.
| Placebo | Drug | Bulk powder for extemporaneous preparation for oral solutions |
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| Hour 0, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 24, 36, 48, and 72 post-dose in each period |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07940369 | Hour 0, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 24, 36, 48, and 72 post-dose in each period |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-07940369 | Hour 0, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 24, 36, 48, and 72 post-dose in each period |
| Plasma Half-Life (t1/2) of PF-07940369 | Hour 0, 0.5, 1, 2, 3, 4, 5, 8, 10, 12, 24, 36, 48, and 72 post-dose in each period |