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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-004326-17 | EudraCT Number | ||
| PF-06651600 | Other Identifier | Alias Study Number | |
| JAK3 | Other Identifier | Alias Study Number |
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This study is a first in human study of PF-06651600. PF-06651600 is being developed for treatment of inflammatory bowel disease. This study will test single and multiple doses of PF-06651600. The goal of the study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-06651600 in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: PF-06651600 or Placebo | Experimental | Single ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK. |
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| Cohort 2: PF-06651600 or Placebo | Experimental | Single ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK. |
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| Cohort 3: PF-06651600 or Placebo | Experimental | Single ascending doses and multiple ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK. |
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| Cohort 4: PF-06651600 or Placebo | Experimental | Single ascending doses and multiple ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK. |
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| Cohort 5: PF-06651600 or Placebo | Experimental | Single ascending doses and multiple ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06651600 or Placebo | Drug | PF-06651600 or placebo will be administered as an extemporaneously prepared solution in each cohort. |
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| Measure | Description | Time Frame |
|---|---|---|
| 24 hour creatinine clearance (Single Dose) | 24 hour urine creatinine clearance in healthy subjects participating in the single dose periods. For the single dose period, assessment occurs on Study Days 0 and 1. | Single dose period, Day 0 (baseline) and 24 hours post dose Day 1. |
| 24 hour creatinine clearance (Multiple Dose) | 24 hour urine creatinine clearance in healthy subjects participating in the multiple dose period. For the multiple ascending dose period assessments occur on Study Days 7 and 14. | Multiple dose period, Days 0 (baseline), 7 and 14. |
| Change from baseline in urine volume (Single Dose) | For the single dose period, assessment occurs on Study Days 0 and 1. | Single dose period, Day 0 (baseline) and 24 hours post dose Day 1. |
| Change from baseline in urine electrolytes (Single Dose) | For the single dose period, assessment occurs on Study Days 0 and 1. | Single dose period, Day 0 (baseline) and 24 hours post dose Day 1. |
| Change from baseline in urine osmolality (Single Dose) | For the single dose period, assessment occurs on Study Days 0 and 1. | Single dose period, Day 0 (baseline) and 24 hours post dose Day 1. |
| Change from baseline of urine volume (Multiple Dose) | For the multiple ascending dose period assessments occur on Study Days 7 and 14. | Multiple dose period, Days 0 (baseline), 7 and 14. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) for PF-06651600 (Single Dose) | Maximum Observed Plasma Concentration (Cmax) | 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose |
| Maximum Observed Plasma Concentration (Cmax) for PF-06651600 (Multiple Dose) |
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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 | B-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 or Placebo | Experimental | Single ascending doses and multiple ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK. |
|
| Cohort 7: PF-06651600 or Placebo | Experimental | Single ascending doses and multiple ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK. |
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| Cohort 8: PF-06651600 or Placebo | Experimental | Single ascending doses and multiple ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK. |
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| Cohort 9: PF-06651600 or Placebo | Experimental | Multiple ascending doses of PF-06651600 or placebo to evaluate safety, tolerability and PK. |
|
| Change from baseline of urine electrolytes (Multiple Dose) |
For the multiple ascending dose period assessments occur on Study Days 7 and 14. |
| Multiple dose period, Days 0 (baseline), 7 and 14. |
| Change from baseline in urine osmolality (Multiple Dose) | For the multiple ascending dose period assessments occur on Study Days 7 and 14. | Multiple dose period, Days 0 (baseline), 7 and 14. |
Maximum Observed Plasma Concentration (Cmax) |
| Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose) |
| Time to Reach Maximum Observed Plasma Concentration (Cmax) for PF-06651600 (Single Dose) | Time to Reach Maximum Observed Plasma Concentration (Cmax) | 0, 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 (Multiple Dose) | Time to Reach Maximum Observed Plasma Concentration (Cmax) | Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose) |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-06651600 (Single Dose) | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) | 0, 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 (Single Dose) | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose |
| Dose Normalized Maximum Observed Plasma Concentration (Cmaxdn) for PF-06651600 (Single Dose) | Dose Normalized Maximum Observed Plasma Concentration (Cmaxdn) | 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose |
| Dose Normalized Maximum Observed Plasma Concentration (Cmaxdn) for PF-06651600 (Multiple Dose) | Dose Normalized Maximum Observed Plasma Concentration (Cmaxdn) | Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose) |
| Dose Normalized Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinfdn) for PF-06651600 (Single Dose) | Dose Normalized Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinfdn) | 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose |
| Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClastdn) for PF-06651600 (Single Dose) | Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClastdn) | 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose |
| Plasma Decay Half-Life (t1/2) for PF-06651600 (Single Dose) | Plasma Decay Half-Life (t1/2) | 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose |
| Plasma Decay Half-Life (t1/2) for PF-06651600 (Multiple Dose) | Plasma Decay Half-Life (t1/2) | Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose) |
| Mean Resonance Time (MRT) for PF-06651600 (Single Dose) | Mean Resonance Time (MRT) | 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose |
| Mean Resonance Time (MRT) for PF-06651600 (Multiple Dose) | Mean Resonance Time (MRT) | Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose) |
| Apparent Volume of Distribution (Vz/F) for PF-06651600 (Single Dose) | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed. | 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose |
| Apparent Volume of Distribution (Vz/F) for PF-06651600 (Multiple Dose) | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed. | Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose) |
| Apparent Total Body Clearance (CL/F) for PF-06651600 (Single Dose) | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent total body clearance (CL/F) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. | 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48 hours post dose |
| Apparent Total Body Clearance (CL/F) for PF-06651600 (Multiple Dose) | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Apparent total body clearance (CL/F) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. | Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose) |
| Minimum Observed Plasma Concentration (Cmin) for PF-06651600 (Multiple Dose) | Minimum Observed Plasma Concentration (Cmin) | Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose) |
| Average Concentration for Dosing Interval (12 or 24 hours) (Cav) for PF-06651600 (Multiple Dose) | Average Concentration for Dosing Interval (12 or 24 hours) (Cav) | Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose) |
| Area Under the Curve for Dosing Interval (12 or 24 hours) for PF-06651600 (Multiple Dose) | Area Under the Curve for Dosing Interval (12 or 24 hours) | Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose) |
| Dose Normalized Area Under the Curve for Dosing Interval (12 or 24 hours) for PF-06651600 (Multiple Dose) | Dose Normalized Area Under the Curve for Dosing Interval (12 or 24 hours) | Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose) |
| Peak to Trough Fluctuation (PTF) for PF-06651600 (Multiple Dose) | Peak to Trough Fluctuation (PTF) | Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose) |
| Observed Accumulation Ratio (Rac) for PF-06651600 (Multiple Dose) | Observed Accumulation Ratio (Rac) | Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose) |
| Observed Accumulation Ratio for Cmax (RacCmax) for PF-06651600 (Multiple Dose) | Observed Accumulation Ratio for Cmax (RacCmax) | Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose) |
| Steady State Accumulation Ratio (Rss) for PF-06651600 (Multiple Dose) | Steady State Accumulation Ratio (Rss) | Days 1, 4, 6, 8, 10, 12 and 14 (0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post dose) |
| Amount of PF-066561600 Excreted Unchanged (Multiple Dose) | Concentration in urine. | Day 14 (12, 24 hours post dose) |
| Change from baseline of BCL2 gene expression in whole blood (Single Dose) | Days -1 and 1 (0, 1, 2, 4, 8, 12 and 24 hours post dose) |
| Change from baseline of BCL2 gene expression in whole blood (Multiple Dose) | Days 1, 5, 10, 14 (0, 1, 2, 4, 8, 12 and 24 hours post dose), 16, and 28 |
| Change from baseline of IP-10 protein concentration in serum (Multiple Dose) | Days 0, 2, 7, 14 (0, and 16 hours post dose) and 16 |
| Change from baseline of hsCRP protein concentration in serum (Multiple Dose) | Days 0, 2, 7, 14 (0, and 16 hours post dose) and 16 |
| Change from baseline of reticulocyte counts in whole blood (Single Dose) | Days 0, 2, 3, and 7 |
| Change from baseline of neutrophil counts in whole blood (Single Dose) | Days 0, 2, 3, and 7 |
| Change from baseline of hemoglobin level whole blood (Single Dose) | Days 0, 2, 3, and 7 |
| Change from baseline of reticulocyte counts in whole blood (Multiple Dose) | Days 0, 4, 8, 12, 14 (pre-dose) 15, and 28 |
| Change from baseline of neutrophil counts in whole blood (Multiple Dose) | Days 0, 4, 8, 12, 14 (pre-dose) 15, and 28 |
| Change from baseline of hemoglobin level in whole blood (Multiple Dose) | Days 0, 4, 8, 12, 14 (pre-dose) 15, and 28 |
| Renal Clearance (Multiple Dose) | Day 1, Day 14 (12, 24 hours post dose) |
| Percentage of PF-066561600 Excreted Unchanged (Multiple Dose) | Concentration in urine. | Day 14 (12, 24 hours post dose) |
| Change from baseline of IP-10 gene expression in blood (Multiple Dose) | Days 0, 5, 10, 14 (0, 1, 2, 4, 8 and 12 hours post dose) and 16 |
| Change from baseline of IP-10 gene expression in blood (Single Dose) | Days 0, 1 (0, 1, 2, 4, 8 and 12 hours post dose) and 16 |
| 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. |
| 27791347 | Derived | Telliez JB, Dowty ME, Wang L, Jussif J, Lin T, Li L, Moy E, Balbo P, Li W, Zhao Y, Crouse K, Dickinson C, Symanowicz P, Hegen M, Banker ME, Vincent F, Unwalla R, Liang S, Gilbert AM, Brown MF, Hayward M, Montgomery J, Yang X, Bauman J, Trujillo JI, Casimiro-Garcia A, Vajdos FF, Leung L, Geoghegan KF, Quazi A, Xuan D, Jones L, Hett E, Wright K, Clark JD, Thorarensen A. Discovery of a JAK3-Selective Inhibitor: Functional Differentiation of JAK3-Selective Inhibition over pan-JAK or JAK1-Selective Inhibition. ACS Chem Biol. 2016 Dec 16;11(12):3442-3451. doi: 10.1021/acschembio.6b00677. Epub 2016 Nov 10. |