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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-515421-28-00 | Registry Identifier | CTIS (EU) |
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The purpose of this clinical trial is to learn about the safety and tolerability of the study medicine (called PF-07941944) in healthy participants.
This study is seeking participants who:
The investigators will compare the experiences of people receiving the study medicine to those of the people who do not. This will help the investigators determine if the study medicine is safe and well tolerated.
Participants enrolled in Part 1 will take part in this study for approximately 4 months. Participants enrolled in Part 2 or Part 3 will take part in this study for approximately 2.5 months. Study visits will take place at the study clinic. The study team will also call participants once at the end of the study over the phone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 | Experimental | Single ascending dose of PF-07941944 or placebo in healthy adult participants |
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| Part 2 | Experimental | Multiple doses of PF-07941944 or placebo in healthy adult participants |
|
| Part 3 (Optional) | Experimental | Period 1, single dose of Midazolam. Period 2, multiple doses of PF-07941944 + Midazolam |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-07941944 | Drug | Oral formulation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs) | Part 1 and Part 2 | Baseline through end of study, approximately 16 weeks |
| Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities | Part 1 and Part 2 | Baseline through end of study, approximately 16 weeks |
| Number of Participants With Clinically Significant Change From Baseline in Vital Signs | Part 1 and Part 2 | Baseline through end of study, approximately 16 weeks |
| Number of Participants With Change From Baseline in Electrocardiogram (ECG) Findings | Part 1 and Part 2 | Baseline through end of study, approximately 16 weeks |
| Maximum Observed Plasma Concentration (Cmax) | Part 3 | Baseline through end of study, approximately 16 weeks |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) | Part 3 - if data permit | Baseline through end of study, approximately 16 weeks |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | Part 3 - If AUCinf not collected | Baseline through end of study, approximately 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Part 1 and Part 2 | Baseline through end of study, approximately 16 weeks |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | Part 1 and Part 2 |
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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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| ID | Term |
|---|---|
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Placebo |
| Drug |
Oral formulation |
|
| Midazolam | Drug | Oral formulation |
|
| Baseline through end of study, approximately 16 weeks |
| AUClast | Part 1 - if data permit | Baseline through end of study, approximately 16 weeks |
| AUCinf | Part 1 - if data permit | Baseline through end of study, approximately 16 weeks |
| Plasma Decay Half-Life (t1/2) | Part 1 and Part 2 - if data permit | Baseline through end of study, approximately 16 weeks |
| Area Under the Curve from Time Zero to end of dosing interval (AUCtau) | Part 2 | Baseline through end of study, approximately 16 weeks |
| Number of Participants With Treatment Emergent Treatment-Related AEs | Part 3 - Optional | Baseline through end of study, approximately 16 weeks |
| Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities | Part 3 - Optional | Baseline through end of study, approximately 16 weeks |
| Number of Participants With Clinically Significant Change From Baseline in Vital Signs | Part 3 - Optional | Baseline through end of study, approximately 16 weeks |
| Number of Participants With Change From Baseline in ECG Findings | Part 3 - Optional | Baseline through end of study, approximately 16 weeks |
| D006571 | Heterocyclic Compounds |