Overview
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.
Description
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.
Eligibility
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).