Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1
8 participants
INTERVENTIONAL
2019-08-19
2020-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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PF-06651600 Severe Renal Impairment
This arm includes participants with severe renal impairment who will receive oral doses of PF-06651600 50 mg on Day 1 through Day 10
PF-06651600
PF-06651600 50 mg oral tablets will be administered on Days 1 to 10
PF-06651600 Normal Renal Function
This arm includes participants with normal renal function who will receive oral doses of PF-06651600 50 mg on Day 1 through Day 10
PF-06651600
PF-06651600 50 mg oral tablets will be administered on Days 1 to 10
PF-06651600 Moderate Renal Impairment
This arm is in Part 2 which will be conducted if decision criterion to proceed to Part 2 is met. This arm includes participants with moderate renal impairment who will receive oral doses of PF-06651600 50 mg on Day 1 through Day 10
PF-06651600
PF-06651600 50 mg oral tablets will be administered on Days 1 to 10
PF-06651600 Mild Renal Impairment
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 renal impairment who will receive oral doses of PF-06651600 50 mg on Day 1 through Day 10.
PF-06651600
PF-06651600 50 mg oral tablets will be administered on Days 1 to 10
Interventions
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PF-06651600
PF-06651600 50 mg oral tablets will be administered on Days 1 to 10
Eligibility Criteria
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Inclusion Criteria
* Meet the following eGFR criteria during the screening period based upon MDRD equation:
* Severe renal impairment: eGFR \<30 mL/min but not requiring hemodialysis
* Moderate renal impairment (Part 2 only): eGFR \>/=30 mL/min and \<60 mL/min
* Mild renal impairment (Part 2 only): eGFR between 60 and 89 mL/min
* Any form of renal impairment except acute nephritic syndrome (subjects with history of previous nephritic syndrome but in remission can be included)
* Stable drug regimen
Exclusion Criteria
* Renal transplant recipients
* Urinary incontinence without catheterization
* Subjects with clinically significant infections within the past 6 months prior to first dose of study drug, evidence of active or chronic infection requiring oral treatment within 4 weeks prior, history of disseminated herpes simplex or recurrent or disseminated herpes zoster
* Subjects with malignancy or with a history of malignancy, with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of skin or cervical carcinoma in situ
* HIV, Hepatitis B, or Hepatitis C infection
* Subjects requiring hemodialysis and peritoneal dialysis
* Screening BP \>/=180 mmHg (systolic) or \>/=110 mmHg (diastolic)
* Screening 12-lead ECG demonstrating QTcF \>470 msec
18 Years
75 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Investigational Drug Services (IDS) University of Miami Hospitals and Clinics
Miami, Florida, United States
University of Miami Division of Clinical Pharmacology
Miami, Florida, United States
Prism Clinical Research, LLC
Saint Paul, Minnesota, United States
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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B7981020
Identifier Type: -
Identifier Source: org_study_id
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