NCT04260464

Renal Impairment Study of PF-06700841

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Healthy Volunteer
• Renal Impairment

Interventions

Type	Name	Description
DRUG	PF-06700841	A single dose of 30 mg PF-06700841 will be administered on Day 1

Timeline

• Start date: 2020-07-03
• Primary completion: 2022-05-04
• Completion: 2022-05-04
• First posted: 2020-02-07
• Last updated: 2024-01-22
• Results posted: 2024-01-22

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study