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| ID | Type | Description | Link |
|---|---|---|---|
| NCT06659250 | Registry Identifier | ClinicalTrials.gov |
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The purpose of this study is to learn about how different amounts of study medicine called PF-06414300 acts and is changed and eliminated from the body of healthy adult participants. The amount of PF-06414300 in blood after the medicine is taken by mouth will also be measured.
The study is seeking for participants who:
All participants in this study will receive either PF-06414300 or placebo (dummy pill) by chance. The study will have 2 parts; in the first part of the study (Part A), each participant will receive a total of 4 doses of PF-06414300 or placebo with at least 10 to 14 days between each dose. After each dose, participants will stay in study clinic for 4 to 5 days.
In the second part of the study (Part B), each participant will receive a total of 10 doses of PF-06414300 or placebo and participants will stay in study clinic for 14 days.
An optional Japanese cohort may be done later. The planned duration of participation from screening to follow up in Part A and B of this study is up to 12 to 14 weeks and 10 to 12 weeks, respectively.
Participants will also have their blood collected by the study doctors several times.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-06414300 | Experimental | Participants will receive single or multiple ascending oral doses of PF-06414300 |
|
| Placebo | Placebo Comparator | Participants will receive matching placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06414300 | Drug | Participants will receive oral ascending doses. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events (AE) observed after single or multiple doses | Day 1 up to Day 28 (Part A)/Day 1 up to Day 38 (Part B) | |
| Number of Serious AE observed after single or multiple doses | Day 1 up to Day 28 (Part A)/Day 1 up to Day 38 (Part B) | |
| Number of participants with abnormal vital sign changes following single or multiple ascending doses | Day 1 up to Day 28 (Part A)/Day 1 up to Day 38 (Part B) | |
| Number of Participants with Electrocardiogram (ECG) Abnormalities including QT and QTcF interval following single or multiple ascending dose | Day 1 up to Day 28 (Part A)/Day 1 up to Day 38 (Part B) | |
| Number of participants with clinically significant laboratory values | Day 1 up to Day 28 (Part A)/Day 1 up to Day 38 (Part B) |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) Part A | Day 1 up to Day 4 (Part A) | |
| Maximum Observed Plasma Concentration (Cmax) Part A | Day 1 up to Day 4 (Part A) |
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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 |
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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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| Placebo |
| Drug |
Participants will receive matching placebo. |
|
| Time to Reach Maximum Observed Plasma Concentration (Tmax) Part A | Day 1 up to Day 4 (Part A) |
| AUClast Part B | Day 1 up to Day 10 (Part B) |
| Cmax Part B | Day 1 up to Day 10 (Part B) |
| Tmax Part B | Day 1 up to Day 10 (Part B) |