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| ID | Type | Description | Link |
|---|---|---|---|
| GBT BEFE (adult formulation) | Other Identifier | Alias Study Number |
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The purpose of this study is to compare two finished products of PF-07940367 in terms of the uptake into the blood stream.
This study is seeking participants who are:
- Healthy male or female participants aged 18 years or older.
All participants in this study will receive PF-07940367 once by mouth. The participants may receive different tablets by mouth for PF-07940367.
The study will compare experiences of people receiving two different products of PF-07940367. This will help understand how much PF-07940367 is taken up into the blood for each product given.
Participants will take part in the study for about 112 days. During this time, participants will have to stay onsite for 5 days. There will be up to 2 additional onsite study visits and 3 remote (telephone call) study visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A: PF-07940367 Product II | Experimental | tablet by mouth |
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| Treatment B: PF-07940367 Product I | Experimental | tablet by mouth |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-07940367 | Drug | Participants to receive a single dose of PF-07940367 product II 150 mg by mouth |
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| Measure | Description | Time Frame |
|---|---|---|
| Area under the whole blood concentration versus time curve (AUC) from time zero (pre-dose) to 336 hours (AUC336) of PF-07940367 dose to evaluate pharmacokinetic comparability of two PF-07940367 products | 0 hours (pre-dose) to 336 hours post-PF-07940367 dose |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (AEs) | From baseline up to 56 days after PF-07940367 dose | |
| Number of Participants With Clinically Significant Laboratory Abnormalities | From baseline up to 336 hours after PF-07940367 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 |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials, LLC | Anaheim | California | 92801 | United States |
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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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| PF-07940367 | Drug | Participants to receive a single dose of PF-07940367 product I 150 mg by mouth |
|
| Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings | From baseline up to 96 hours after PF-07940367 dose |
| Number of Participants With Clinically Significant Vital Signs | From baseline up to 336 hours after PF-07940367 dose |
| Maximum Observed Whole Blood Concentration (Cmax) of PF-07940367 for two PF-07940367 products | 0 hours (pre-dose) to 336 hours post-PF-07940367 dose |
| Area under the whole blood concentration versus time curve (AUC) from time zero (pre-dose) to the last quantifiable concentration (AUClast) of PF-07940367 for two PF-07940367 products | 0 hours (pre-dose) to 336 hours post-PF-07940367 dose |
| Time to Maximum Observed Whole Blood Concentration (Tmax) of PF-07940367 for two PF-07940367 products | 0 hours (pre-dose) to 336 hours post-PF-07940367 dose |