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The purpose of this study is to compare three finished products of PF-06954522 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-06954522 once by mouth. The participants may receive different tablets by mouth for PF-06954522.
The study will compare experiences of people receiving three different products of PF-06954522. This will help understand how much PF-06954522 is taken up into the blood for each product given.
Participants will take part into the study for about 77 days. During this time participants will have to stay onsite for 21 days. There will be one follow up (by telephone) study visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | Participants will receive a single dose (Dose Level 1 and 2) of PF-06954522 as: Formulation 1 , Formulation 2, and Formulation 3 under fasted conditions in Periods 1, 2, and 3, respectively, followed by Formulations 2 and 3 under fed conditions in Periods 4 and 5, respectively. |
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| Sequence 2 | Experimental | Participants will receive a single dose (Dose Level 1 and 2) of PF-06954522 as: Formulation 2, Formulation 3, and Formulation 1 under fasted conditions in Periods 1, 2, and 3, respectively, followed by Formulations 2 and 3 under fed conditions in Periods 4 and 5, respectively. |
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| Sequence 3 | Experimental | Participants will receive a single dose (Dose Level 1 and 2) of PF-06954522 as: Formulation 3, Formulation 1, and Formulation 2, under fasted conditions in Periods 1, 2, and 3, respectively, followed by Formulations 2 and 3 under fed conditions in Periods 4 and 5, respectively. |
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| Sequence 4 | Experimental | Participants will receive a single dose (Dose Level 1 and 2) of PF-06954522 as: Formulation 3, Formulation 2, and Formulation 1 under fasted conditions in Periods 1, 2, and 3, respectively, followed by Formulations 3 and 2 under fed conditions in Periods 4 and 5, respectively. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06954522 IR (Formulation 1) | Drug | Participants to receive a single dose (Dose Level 1 and 2) of PF-06954522 Formulation 1 by mouth |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve from time zero to extrapolated infinite time (AUCinf) of PF-06954522 to evaluate the relative bioavailability of three PF-06954522 formulations administered in the fasted state. | 0 hours (pre-dose) to 72 hours (extrapolated to infinite time) post PF-06954522 dose in each period | |
| Maximum Observed Plasma Concentration (Cmax) of PF-06954522 to evaluate the relative bioavailability of three PF-06954522 formulations administered in the fasted state. | 0 hours (pre-dose) to 72 hours post PF-06954522 dose in each period |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment-Emergent Adverse Events (AEs) | From baseline up to 49 days after PF-06954522 dose in Period 1 Day 1 | |
| Number of Participants with Laboratory Test Abnormalities | From baseline up to 72 hours after PF-06954522 dose in each period |
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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 - New Haven | New Haven | Connecticut | 06511 | United States | ||
| Pfizer Clinical Research Unit |
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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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| Sequence 5 | Experimental | Participants will receive a single dose (Dose Level 1 and 2) of PF-06954522 as: Formulation 1, Formulation 3, and Formulation 2 under fasted conditions in Periods 1, 2, and 3, respectively, followed by Formulations 3 and 2 under fed conditions in Periods 4 and 5, respectively. |
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| Sequence 6 | Experimental | Participants will receive a single dose (Dose Level 1 and 2) of PF-06954522 as: Formulation 2, Formulation 1, and Formulation 3 under fasted conditions in Periods 1, 2, and 3, respectively, followed by Formulations 3 and 2 under fed conditions in Periods 4 and 5, respectively. |
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| PF-06954522 MR (Formulation 2) | Drug | Participants to receive a single dose (Dose Level 1 and 2) of PF-06954522 Formulation 2 by mouth. |
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| PF-06954522 MR (Formulation 3) | Drug | Participants to receive a single dose (Dose Level 1 and 2) of PF-06954522 Formulation 3 by mouth |
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| Number of Participants with Summary of Post-Baseline Vital Signs Data | From baseline up to 72 hours after PF-06954522 dose in each period |
| Number of Participants who met Defined Electrocardiogram (ECG) Criteria | From baseline up to 72 hours after PF-06954522 dose in each period |
| Area Under the Curve from time zero to extrapolated infinite time (AUCinf) of PF-06954522 to evaluate the relative bioavailability of two PF-06954522 formulations administered in the fed state compared to fasted state. | 0 hours (pre-dose) to 72 hours (extrapolated to infinite time) post PF-06954522 dose in each period |
| Maximum Observed Plasma Concentration (Cmax) of PF-06954522 to evaluate the relative bioavailability of two PF-06954522 formulations administered in the fed state compared to the fasted state. | 0 hours (pre-dose) to 72 hours post PF-06954522 dose in each period |
| New Haven |
| Connecticut |
| 06511 |
| United States |