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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-004857-41 | EudraCT Number |
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PF-06651600 is being developed for treatment of inflammatory bowel disease. This study will test the bioavailability of a solid dose formulation of PF-06651600 compared to an oral solution formulation under fasting conditions and the effect of a high fat meal on the bioavailability of the solid dose formulation of PF-06651600 in healthy subjects. Safety and tolerability of the tablet and oral solution formulations of PF-06651600 will be assessed under fasting and fed conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: PF-06651600 | Experimental | Single dose of PF-06651600 50 mg tablet (under fasted condition and following high fat meal) and 50 mg oral formulation (under fasted condition) to evaluate bioavailability. |
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| Cohort 2: PF-06651600 | Experimental | Single dose of PF-06651600 50 mg tablet (under fasted condition and following high fat meal) and 50 mg oral formulation (under fasted condition) to evaluate bioavailability. |
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| Cohort 3: PF-06651600 | Experimental | Single dose of PF-06651600 50 mg tablet (under fasted condition and following high fat meal) and 50 mg oral formulation (under fasted condition) to evaluate bioavailability. |
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| Cohort 4: PF-06651600 | Experimental | Single dose of PF-06651600 50 mg tablet (under fasted condition and following high fat meal) and 50 mg oral formulation (under fasted condition) to evaluate bioavailability. |
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| Cohort 5: PF-06651600 | Experimental | Single dose of PF-06651600 50 mg tablet (under fasted condition and following high fat meal) and 50 mg oral formulation (under fasted condition) to evaluate bioavailability. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06651600 | Drug | PF-06651600 will be administered as a tablet and extemporaneously prepared solution in each cohort. |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-06651600 | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) | 0, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-06651600 | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | 0, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose |
| Time to Reach Maximum Observed Plasma Concentration (Cmax) for PF-06651600 | Time to Reach Maximum Observed Plasma Concentration (Cmax) | 0, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Decay Half Life (t1/2) for PF-06651600 | Plasma Decay Half-Life (t1/2) | 0, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose |
| Time to Reach Maximum Concentration (Tmax) for PF-06651600 |
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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 | 1070 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38267790 | Derived | Saadeddin A, Purohit V, Huh Y, Wong M, Maulny A, Dowty ME, Sagawa K. Virtual Bioequivalence Assessment of Ritlecitinib Capsules with Incorporation of Observed Clinical Variability Using a Physiologically Based Pharmacokinetic Model. AAPS J. 2024 Jan 24;26(1):17. doi: 10.1208/s12248-024-00888-9. | |
| 37917289 | Derived |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| C000614924 | PF-06651600 |
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| Cohort 6: PF-06651600 | Experimental | Single dose of PF-06651600 50 mg tablet (under fasted condition and following high fat meal) and 50 mg oral formulation (under fasted condition) to evaluate bioavailability. |
|
Time to Reach Maximum Concentration (Tmax)
| 0, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose |
| Wojciechowski J, S Purohit V, Huh Y, Banfield C, Nicholas T. Evolution of Ritlecitinib Population Pharmacokinetic Models During Clinical Drug Development. Clin Pharmacokinet. 2023 Dec;62(12):1765-1779. doi: 10.1007/s40262-023-01318-3. Epub 2023 Nov 2. |
| 36977960 | Derived | Purohit V, Huh Y, Wojciechowski J, Plotka A, Salts S, Antinew J, Dimitrova A, Nicholas T. Leveraging Prior Healthy Participant Pharmacokinetic Data to Evaluate the Impact of Renal and Hepatic Impairment on Ritlecitinib Pharmacokinetics. AAPS J. 2023 Mar 28;25(3):32. doi: 10.1208/s12248-023-00792-8. |