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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-003512-41 | EudraCT Number |
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PF-06700841 is a dual Tyrosine kinase 2 (TYK2) Janus kinase 1 (JAK1) inhibitor that is being developed for oral treatment of adult patients with Inflammatory Bowel Disease (IBD).This open-label study will evaluate the pharmacokinetics of PF-06700841 following single oral doses of immediate release (IR) and modified release (MR) tablets in healthy, adult participants under fasted conditions. This is an open label, single dose, randomized, 2 period, 2- sequence crossover study in a single cohort of approximately 8 (minimum 6) healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-06700841: IR followed by MR | Experimental | Participants receive PF-06700841 Immediate release tablets (IR) followed by PF-06700841 Modified release tablets (MR) |
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| PF-06700841: MR followed by IR | Experimental | Participants receive PF-06700841 Modified release tablets (MR) followed by PF-06700841 Immediate release tablets (IR) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06700841 Immediate release tablets | Drug | Small molecule tablets in immediate release form |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of PF-06700841 | pre-dose, 1,2,4,6,8,10,12,16,24,28,32,36,48 hour post-dose | |
| Area under the plasma concentration-time curve from time zero to the last measured concentration (AUClast) of PF-06700841 | pre-dose, 1,2,4,6,8,10,12,16,24,28,32,36,48 hour post-dose | |
| Time to reach maximum observed plasma concentration (Tmax) of PF-06700841 | pre-dose, 1,2,4,6,8,10,12,16,24,28,32,36,48 hour post-dose | |
| Area under the plasma concentration-time curve from time zero to extrapolated infinite time (AUCinf) of PF-06700841 if data permit | pre-dose, 1,2,4,6,8,10,12,16,24,28,32,36,48 hour post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in 12-Lead Electrocardiogram (ECG) parameters - PR interval, QRS complex, QT interval and QTC interval | Pre-dose and 48 hours post-dose | |
| Change from baseline in heart rate | Pre-dose and 48 hours post-dose |
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Key Inclusion Criteria:
Key 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 | B-1070 | Belgium |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
| 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 |
|---|---|
| C000630838 | PF-06700841 |
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| PF-06700841 Modified release tablets | Drug | Small molecule tablets in modified release form |
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| Change from baseline in blood pressure | Pre-dose and 48 hours post-dose |
| Change from baseline in pulse rate | Pre-dose and 48 hours post-dose |
| Change from baseline in oral temperature | Pre-dose and 48 hours post-dose |
| Number of participants with laboratory abnormalities | Baseline and 48 hours post-dose |
| Number of participants with Treatment -Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs | Baseline to 48 hours post-dose |