Renal Impairment Study of PF-06700841

Launched by PFIZER · Feb 5, 2020

Keywords

ClinConnect Summary

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 ...

Gender

ALL

Eligibility criteria

• 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).