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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-520558-12-00 | Registry Identifier | CTIS (EU) |
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The purpose of this study is to learn about the safety and tolerability of a study medicine called PF-07940369 when it is taken by mouth in different amounts and/or at multiples times a day by healthy adult participants. The study will also look at the pharmacokinetics of PF-07940369 (how the medicine is changed and eliminated from the body).
The study is seeking participants that are:
In each dose group, 10 participants will be randomly assigned to take PF-07940369 (8 participants) or placebo (2 participants). A placebo does not have any medicine in it but looks just like the medicine being studied. Participants will receive the study medication by mouth 1 to 2 times a day for 14 days while admitted to the study clinic.
The study team will look for the experiences of people receiving the study medicine. This will help the team see if the study medicine is safe and if the study can go to the next dose group. An optional Japanese group may be conducted later.
Participants will take part in this study for 10 weeks. During this time, the participants will stay in the study clinic for 16 days to receive the study medication. The participants will have multiple blood samples drawn during dosing for safety laboratory assessments and up to 48 hours after receiving the last dose of PF-07940369 to look at how the body processes the study medicine. After being discharged from the study clinic, the participants will have a study visit 7 to 10 days after the last dose. The study team will also call participants one time over the phone 28 to 35 days after receiving their last dose on Day 14.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1, PF-07940369 or Placebo | Experimental | Multiple oral dosing |
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| Cohort 2, PF-07940369 or Placebo | Experimental | Multiple oral dosing |
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| Cohort 3, PF-07940369 or Placebo | Experimental | Multiple oral dosing |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-07940369 | Drug | Oral Tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (AEs) | Baseline (Day 0) up to 35 days after last dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of PF-07940369 | Pre-dose (0), 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post-dose | |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-07940369 | Pre-dose (0), 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post-dose |
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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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Randomized, double-blind (investigator- and participant-blinded), sponsor-open, placebo-controlled, multiple ascending oral dose escalation
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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 through 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.
| Placebo | Drug | Oral Tablets |
|
| Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-07940369 | Area under the concentration curve from time 0 to end of dosing interval (AUCtau), where dosing interval is 12 or 24 hours. | Pre-dose (0), 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 hours post-dose |
| Percent of Dose Recovered in Urine as Unchanged Drug (Aetau%) | PF-07940369 urinary PK parameters: Aetau% | 0 to 12 hours or 0 to 24 hours post-dose |