Renal Impairment Study of PF-06700841

Study Overview
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Brief Summary
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The purpose of this study is to characterize the effect of kidney impairment on the blood concentrations of PF-06700841 and its major metabolite. Findings from this study will be used to develop dosing recommendations so that the dose and/or dosing interval may be adjusted appropriately in the presence of kidney disease.

Detailed Description
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This is a Phase 1 non-randomized, open-label, parallel cohort, multi-site study to investigate the effect of renal impairment on the pharmacokinetics, safety and tolerability of PF-06700841 after a single oral dose of 30 mg. Subjects will be selected and categorized into normal renal function or renal impairment groups based on their estimated glomerular filtration rate. Part 1: A total of approximately 16 subjects will be enrolled; approximately 8 subjects with severe renal impairment and approximately 8 with normal renal function. After statistical evaluation of results from Part 1, Part 2 may be conducted with approximately 8 subjects each with moderate and mild renal impairment. The total duration of participation from Screening visit to Day 4 will be a maximum of 32 days and from Screening visit to Follow-up/Contact Visit will a maximum of 67 days.

Official Title
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A PHASE 1, NON-RANDOMIZED, OPEN LABEL, SINGLE DOSE STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF PF-06700841 IN PARTICIPANTS WITH RENAL IMPAIRMENT AND IN HEALTHY PARTICIPANTS WITH NORMAL RENAL FUNCTION

Conditions
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Healthy Volunteer, Renal Impairment

Intervention / Treatment
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* Drug: PF-06700841


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female participants who are between the ages of 18 and 75 years, inclusive, at the Screening visit. Body mass index (BMI) of ≥17.5 to ≤40 kg/m2; and a total body weight >50 kg. Normal, Severe, Moderate and Mild renal function at 2 Screening visits. 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 to first dose Known history of pulmonary embolism or recurrent deep vein thrombosis Any condition possibly affecting drug absorption (eg, prior bariatric surgery, gastrectomy, ileal resection).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PF-06700841 Severe Renal Impairment<br>This arm includes participants with severe renal impairment who will receive a single oral dose of 30 mg PF-06700841 on Day 1 | Drug: PF-06700841<br>* A single dose of 30 mg PF-06700841 will be administered on Day 1<br>|
| Experimental: PF-06700841 Normal Renal Function<br>This arm includes participants with normal renal function who will receive a single oral dose of 30 mg PF-06700841 on Day 1 | Drug: PF-06700841<br>* A single dose of 30 mg PF-06700841 will be administered on Day 1<br>|
| Experimental: PF-06700841 Moderate Renal Impairment<br>This arm includes participants with moderate renal impairment who will receive a single oral dose of 30 mg PF-06700841 on Day 1 | Drug: PF-06700841<br>* A single dose of 30 mg PF-06700841 will be administered on Day 1<br>|
| Experimental: PF-06700841 Mild Renal Impairment<br>This arm includes participants with mild renal impairment who will receive a single oral dose of 30 mg PF-06700841 on Day 1 | Drug: PF-06700841<br>* A single dose of 30 mg PF-06700841 will be administered on Day 1<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the PF-06700841 and M1 concentration-time curve in severe renal impaired participants | Area under the PF-06700841 and M1 concentration-time curve from time 0 to infinity | 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose | 
| Area under the PF-06700841 and M1 concentration-time curve in moderate renal impaired participants | Area under the PF-06700841 and M1 concentration-time curve from time 0 to infinity | 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose | 
| Area under the PF-06700841 and M1 concentration-time curve in mild renal impaired participants | Area under the PF-06700841 and M1 concentration-time curve from time 0 to infinity | 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose | 
| Maximum plasma concentration of PF-06700841 and M1 concentration-time curve in severe renal impaired participants | Maximum plasma concentration of PF-06700841 and M1 | 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose | 
| Maximum plasma concentration of PF-06700841 and M1 concentration-time curve in moderate renal impaired participants | Maximum plasma concentration of PF-06700841 and M1 | 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose | 
| Maximum plasma concentration of PF-06700841 and M1 concentration-time curve in mild renal impaired participants | Maximum plasma concentration of PF-06700841 and M1 | 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with treatment-emergent adverse events of PF-06700841 | Number of subjects with treatment-emergent adverse events | Screening (Day -28) up to follow-up (Day 35) | 
| Number of subjects with clinically relevant changes in clinical laboratory tests of PF-06700841 | Number of subjects with clinical laboratory tests | Screening (Day -28) up to follow-up (Day 35) | 
| Number of subjects with clinically relevant changes in vital signs of PF-06700841 | Number of subjects with vital signs | Screening (Day -28) up to follow-up (Day 35) | 
| Number of subjects with clinically relevant changes in physical examination of PF-06700841 | Number of subjects with physical examination | Screening (Day -28) up to follow-up (Day 35) | 
| Number of subjects with clinically relevant changes in ECG parameters of PF-06700841 | Number of subjects with ECG parameters | Screening (Day -28) up to follow-up (Day 35) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetics