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Renal Impairment Study of PF-06700841

NCT ID: NCT04260464

Last Updated: 2024-01-22

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-03

Study Completion Date

2022-05-04

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.

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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.

Conditions

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Healthy Volunteer Renal Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Single group
Primary Study Purpose

OTHER

Blinding Strategy

NONE

No Masking

Study Groups

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PF-06700841 Severe Renal Impairment

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

Group Type EXPERIMENTAL

PF-06700841

Intervention Type DRUG

A single dose of 30 mg PF-06700841 will be administered on Day 1

PF-06700841 Normal Renal Function

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

Group Type EXPERIMENTAL

PF-06700841

Intervention Type DRUG

A single dose of 30 mg PF-06700841 will be administered on Day 1

PF-06700841 Moderate Renal Impairment

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

Group Type EXPERIMENTAL

PF-06700841

Intervention Type DRUG

A single dose of 30 mg PF-06700841 will be administered on Day 1

PF-06700841 Mild Renal Impairment

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

Group Type EXPERIMENTAL

PF-06700841

Intervention Type DRUG

A single dose of 30 mg PF-06700841 will be administered on Day 1

Interventions

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PF-06700841

A single dose of 30 mg PF-06700841 will be administered on Day 1

Intervention Type DRUG

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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Investigational Drug Services (IDS) University of Miami Hospitals and Clinics, Research Pharmacy

Miami, Florida, United States

Site Status

University of Miami Division of Clinical Pharmacology

Miami, Florida, United States

Site Status

Prism Research LLC dba Nucleus Network

Saint Paul, Minnesota, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=B7931048

To obtain contact information for a study center near you, click here.

Other Identifiers

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B7931048

Identifier Type: -

Identifier Source: org_study_id

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