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The purpose of this study is to characterize the effect of hepatic impairment on the pharmacokinetic(s) (PK) of PF-06651600 following administration of multiple once daily doses of PF-06651600. The safety and tolerability of PF-06651600 will also be evaluated in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-06651600 Moderate Hepatic Impairment | Experimental | This arm includes participants with moderate hepatic impairment who will receive oral doses of PF-06651600 30 mg on Day 1 through Day 10. |
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| PF-06651600 Healthy participants | Experimental | This arm includes healthy adult participants who will receive oral doses of PF-06651600 30 mg on Day 1 through Day 10. |
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| PF-06651600 Mild Hepatic Impairment | Experimental | This arm is in Part 2 which will be conducted if the decision criterion to proceed to Part 2 is met. The arm includes participants with mild hepatic impairment who will receive oral doses of PF-06651600 30 mg on Day 1 through Day 10. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06651600 30 mg | Drug | PF-06651600 in 10 mg oral tablets will be administered on days 1 to 10. |
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| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-time Profile From Time 0 to 24 Hours (AUC24) for PF-06651600 | AUC24 of PF-06651600 pre and post dose. | Hour 0 (pre-dose) on Days 7, 8 and 9, and hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24 hours post-dose on Day 10 |
| Maximum Plasma Concentration (Cmax) for PF-06651600 | Cmax is maximum observed plasma concentration. | Hour 0 (pre-dose) on Days 7, 8 and 9, and hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24 hours post-dose on Day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (All Causalities and Treatment-related) | AEs with all causalities were any untoward medical occurrences in a study participant administered a product which did not necessarily had causal relationship with the treatment or usage. An SAE was an AE resulting in any of the following endpoints or deemed significant for any other reason: death; life threatening (immediate risk of death); inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or considered to be an important medical event. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to 35 days after last dose that were absent before treatment or that worsened relative to pretreatment state. |
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Inclusion Criteria:
Additional Inclusion Criteria for Participants with Normal Hepatic Function:
Additional Inclusion Criteria for Participants with Impaired Hepatic Function:
Exclusion Criteria:
Additional Exclusion Criteria for Participants with Normal Hepatic Function:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, gynecologic or allergic disease
Additional Exclusion Criteria for Participants with Impaired Hepatic Function:
- Has encephalopathy, severe ascites and/or pleural effusion, Child-Pugh score >9 or medical conditions (like hepatorenal syndrome, gastrointestinal hemorrhage, etc.) excluded per protocol
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Division of Clinical Pharmacology | Miami | Florida | 33136 | United States | ||
| Orlando Clinical Research Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37917289 | Derived | 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. |
| 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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Eight participants were originally enrolled in each cohort. Two participants in moderate hepatic impairment cohort who discontinued from study treatment were included as "completed" and 2 additional participants were enrolled to ensure an adequate number of evaluable participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Moderate Hepatic Impairment | Participants with moderate hepatic impairment were administered PF-06651600 30 milligram (mg) once daily (QD) for 10 treatment days. |
| FG001 | Normal Hepatic Function |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 23, 2019 | Mar 1, 2021 |
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| Baseline (Day 0) up to 28 days after last dose of study medication (Day 39) |
| Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality) | Laboratory parameters included: hematology (hemoglobin, hematocrit, erythrocytes, leukocytes, neutrophils, prothrombin time, prothrombin intl. normalized ratio), chemistry (bilirubin, direct bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, albumin, sodium, potassium, calcium, bicarbonate and glucose), urinalysis (glucose, ketones, protein, hemoglobin, urobilinogen, bilirubin and nitrite). Each parameter was evaluated against commonly used and widely accepted criteria. | Baseline (Day 0) up to 28 days after last dose of study medication (Day 39) |
| Number of Participants With Out of Range Vital Signs | Vital signs included supine blood pressure, pulse rate and temperature. The pre-specified out of range criterion for supine diastolic blood pressure was change from baseline equal to or over than (≥) 20 millimeter of mercury (mmHg). Clinical significance of vital signs and out of range criterion were determined at the investigator's discretion. | Baseline (Day 0) up to 28 days after last dose of study medication (Day 39) |
| Number of Adverse Events Leading to Discontinuation | Adverse events result in participants discontinuations from the study drug. | Baseline (Day 0) up to 28 days after last dose of study medication (Day 39) |
| Orlando |
| Florida |
| 32809 |
| United States |
Participants with normal hepatic function were administered PF-06651600 30 milligram (mg) once daily (QD) for 10 treatment days.
| COMPLETED |
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| NOT COMPLETED |
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All 18 participants who were included in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Moderate Hepatic Impairment | Participants with moderate hepatic impairment were administered PF-06651600 30 milligram (mg) once daily (QD) for 10 treatment days. |
| BG001 | Normal Hepatic Function | Participants with normal hepatic function were administered PF-06651600 30 milligram (mg) once daily (QD) for 10 treatment days. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Area Under the Plasma Concentration-time Profile From Time 0 to 24 Hours (AUC24) for PF-06651600 | AUC24 of PF-06651600 pre and post dose. | The analysis population was defined as all participants treated who have at least 1 of the pharmacokinetic (PK) parameters of primary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per milliliter (ng*hr/mL) | Hour 0 (pre-dose) on Days 7, 8 and 9, and hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24 hours post-dose on Day 10 |
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| Primary | Maximum Plasma Concentration (Cmax) for PF-06651600 | Cmax is maximum observed plasma concentration. | The analysis population was defined as all participants treated who have at least 1 of the PK parameters of primary interest. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Hour 0 (pre-dose) on Days 7, 8 and 9, and hour 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 14, 24 hours post-dose on Day 10 |
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| Secondary | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (All Causalities and Treatment-related) | AEs with all causalities were any untoward medical occurrences in a study participant administered a product which did not necessarily had causal relationship with the treatment or usage. An SAE was an AE resulting in any of the following endpoints or deemed significant for any other reason: death; life threatening (immediate risk of death); inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect; or considered to be an important medical event. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to 35 days after last dose that were absent before treatment or that worsened relative to pretreatment state. | All participants assigned to investigational product and who took at least 1 dose of investigational product. | Posted | Count of Participants | Participants | Baseline (Day 0) up to 28 days after last dose of study medication (Day 39) |
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| Secondary | Number of Participants With Laboratory Abnormalities (Without Regard to Baseline Abnormality) | Laboratory parameters included: hematology (hemoglobin, hematocrit, erythrocytes, leukocytes, neutrophils, prothrombin time, prothrombin intl. normalized ratio), chemistry (bilirubin, direct bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, albumin, sodium, potassium, calcium, bicarbonate and glucose), urinalysis (glucose, ketones, protein, hemoglobin, urobilinogen, bilirubin and nitrite). Each parameter was evaluated against commonly used and widely accepted criteria. | All participants assigned to investigational product and who took at least 1 dose of investigational product. | Posted | Count of Participants | Participants | Baseline (Day 0) up to 28 days after last dose of study medication (Day 39) |
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| Secondary | Number of Participants With Out of Range Vital Signs | Vital signs included supine blood pressure, pulse rate and temperature. The pre-specified out of range criterion for supine diastolic blood pressure was change from baseline equal to or over than (≥) 20 millimeter of mercury (mmHg). Clinical significance of vital signs and out of range criterion were determined at the investigator's discretion. | All participants assigned to investigational product and who took at least 1 dose of investigational product. | Posted | Count of Participants | Participants | Baseline (Day 0) up to 28 days after last dose of study medication (Day 39) |
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| Secondary | Number of Adverse Events Leading to Discontinuation | Adverse events result in participants discontinuations from the study drug. | All participants assigned to investigational product and who took at least 1 dose of investigational product. | Posted | Number | adverse events | Baseline (Day 0) up to 28 days after last dose of study medication (Day 39) |
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Baseline (Day 0) up to Day 39 (28 days after last dose of study medication).
Participants were only counted once per hepatic function group per event. If a participant had more than one occurrence in the same Preferred Term event category, only the most severe occurrence was counted.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Moderate Hepatic Impairment | Participants with moderate hepatic impairment were administered PF-06651600 30 milligram (mg) once daily (QD) for 10 treatment days. | 0 | 10 | 1 | 10 | 3 | 10 |
| EG001 | Normal Hepatic Function | Participants with normal hepatic function were administered PF-06651600 30 milligram (mg) once daily (QD) for 10 treatment days. | 0 | 8 | 0 | 8 | 2 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholestasis | Hepatobiliary disorders | MedDRA v22.1 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v22.1 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA v22.1 | Non-systematic Assessment |
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| Arthropod bite | Injury, poisoning and procedural complications | MedDRA v22.1 | Non-systematic Assessment |
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| Hepatic enzyme increased | Investigations | MedDRA v22.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA v22.1 | Non-systematic Assessment |
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Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 22, 2019 | Mar 1, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| C000614924 | PF-06651600 |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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