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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-004664-55 | EudraCT Number |
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This study will estimate the impact of a strong CYP3A4 inhibitor (itraconazole) on the pharmacokinetics of an investigational product (PF-06651600) in healthy adult participants.
This is an open-label, fixed sequence two period study with healthy participants that will receive a single dose of PF-06651600 alone and co-administered with multiple doses of itraconazole at a single center.
Participants will be screened within 28 days of the first dose of the investigational products and if entry criteria are met, the participant will report to the clinic on the day before the Day 1 visit. On Day 1 of Period 1, each participant will receive a 30 mg dose of PF-06651600 and PK samples will be collected for 48 hours. In Period 2, participants will receive itraconazole solution from Day 1-5. On Day 4 of Period 2 the participant will receive 30 mg of PF-06651600 with the itraconazole. PK samples will be collected up to 48 hours after the PF-06651600 dose. Participants will be confined for a total of 9 days in the clinic. The participant will be followed up by phone contact.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-06651600 treatment arm | Experimental | This arm includes two treatment periods. Period 1-Single oral dose of PF-06651600 30 mg as tablets on Day 1 followed by Period 2 in which itraconazole 200 mg (oral solution) is given for 5 days. On Day 4 of Period 2, a single oral dose of PF-06651600 30 mg is given with itraconazole |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06651600 10 mg tablets | Drug | On Day 1 in Period 1, a single oral dose of 30 mg (3 x 10 mg tablets) will be administered. On Day 4 of Period 2, a single oral dose of 30 mg (3 x 10 mg tablets) will be administered after itraconazole. |
| Measure | Description | Time Frame |
|---|---|---|
| Single dose Area under the curve from time zero to infinity [AUC (0-inf)] of PF-06651600 | Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinity. | 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 and 48 hours |
| Maximum observed plasma concentration of PF-06651600 | Peak concentration of PF-06651600 | 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24 and 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events (AEs) | Baseline up to 35 days | |
| Number of adverse events leading to discontinuation | Baseline up to 35 days | |
| Number of participants with clinically significant change in vital signs from Baseline |
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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 | Be-bru | 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 |
|---|---|
| C000614924 | PF-06651600 |
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Itraconazole Solution 200 mg | Drug | Itraconazole 200 mg will be administered as 20 mL (10 mg/mL) oral solution once daily on Days 1-5 in Period 2. On Day 4 of Period 2, co-administration of itraconazole 200 mg and PF-06651600 30 mg will occur. Itraconazole will be administered first followed by PF-06651600 tablets. |
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| Baseline to Day 9 |
| Number of participants with clinically significant abnormalities in clinical laboratory values | Baseline to Day 9 |
| D010879 |
| Piperazines |