Renal Impairment Study of PF-06700841

Pfizer

Status and phase: Completed; Phase 1

Conditions: Renal Impairment; Healthy Volunteer

Treatments: Drug: PF-06700841

Study type: Interventional

Funder types: Industry

Identifiers

NCT04260464

B7931048

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 4 patient groups

PF-06700841 Severe Renal Impairment

Experimental group

Description:

This arm includes participants with severe renal impairment who will receive a single oral dose of 30 mg PF-06700841 on Day 1

Treatment:

Drug: PF-06700841

PF-06700841 Normal Renal Function

Experimental group

Description:

This arm includes participants with normal renal function who will receive a single oral dose of 30 mg PF-06700841 on Day 1

Treatment:

Drug: PF-06700841

PF-06700841 Moderate Renal Impairment

Experimental group

Description:

This arm includes participants with moderate renal impairment who will receive a single oral dose of 30 mg PF-06700841 on Day 1

Treatment:

Drug: PF-06700841

PF-06700841 Mild Renal Impairment

Experimental group

Description:

This arm includes participants with mild renal impairment who will receive a single oral dose of 30 mg PF-06700841 on Day 1

Treatment:

Drug: PF-06700841