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Renal Impairment Study of PF-06700841

Primary Purpose

Healthy Volunteer, Renal Impairment

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

PF-06700841

About this trial

This is an interventional other trial for Healthy Volunteer focused on measuring Pharmacokinetics

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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).

Sites / Locations

Investigational Drug Services (IDS) University of Miami Hospitals and Clinics, Research Pharmacy
University of Miami Division of Clinical Pharmacology
Prism Research LLC dba Nucleus Network

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

PF-06700841 Severe Renal Impairment

PF-06700841 Normal Renal Function

PF-06700841 Moderate Renal Impairment

PF-06700841 Mild Renal Impairment

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Area under the PF-06700841 and M1 concentration-time curve in severe renal impaired participants

Area under the PF-06700841 and M1 concentration-time curve from time 0 to infinity

Area under the PF-06700841 and M1 concentration-time curve in moderate renal impaired participants

Area under the PF-06700841 and M1 concentration-time curve from time 0 to infinity

Area under the PF-06700841 and M1 concentration-time curve in mild renal impaired participants

Area under the PF-06700841 and M1 concentration-time curve from time 0 to infinity

Maximum plasma concentration of PF-06700841 and M1 concentration-time curve in severe renal impaired participants

Maximum plasma concentration of PF-06700841 and M1

Maximum plasma concentration of PF-06700841 and M1 concentration-time curve in moderate renal impaired participants

Maximum plasma concentration of PF-06700841 and M1

Maximum plasma concentration of PF-06700841 and M1 concentration-time curve in mild renal impaired participants

Maximum plasma concentration of PF-06700841 and M1

Secondary Outcome Measures

Number of subjects with treatment-emergent adverse events of PF-06700841

Number of subjects with treatment-emergent adverse events

Number of subjects with clinically relevant changes in clinical laboratory tests of PF-06700841

Number of subjects with clinical laboratory tests

Number of subjects with clinically relevant changes in vital signs of PF-06700841

Number of subjects with vital signs

Number of subjects with clinically relevant changes in physical examination of PF-06700841

Number of subjects with physical examination

Number of subjects with clinically relevant changes in ECG parameters of PF-06700841

Number of subjects with ECG parameters

Full Information

NCT ID

NCT04260464

First Posted

February 5, 2020

Last Updated

October 12, 2022

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT04260464

Brief Title

Renal Impairment Study of PF-06700841

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Completed

Study Start Date

July 3, 2020 (Actual)

Primary Completion Date

May 4, 2022 (Actual)

Study Completion Date

May 4, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy Volunteer, Renal Impairment

Keywords

Pharmacokinetics

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Model Description

Single group

Masking

None (Open Label)

Masking Description

No Masking

Allocation

Non-Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PF-06700841 Severe Renal Impairment

Arm Type

Experimental

Arm Description

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

Arm Title

PF-06700841 Normal Renal Function

Arm Type

Experimental

Arm Description

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

Arm Title

PF-06700841 Moderate Renal Impairment

Arm Type

Experimental

Arm Description

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

Arm Title

PF-06700841 Mild Renal Impairment

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

PF-06700841

Intervention Description

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

Primary Outcome Measure Information:

Title

Area under the PF-06700841 and M1 concentration-time curve in severe renal impaired participants

Description

Area under the PF-06700841 and M1 concentration-time curve from time 0 to infinity

Time Frame

0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose

Title

Area under the PF-06700841 and M1 concentration-time curve in moderate renal impaired participants

Description

Area under the PF-06700841 and M1 concentration-time curve from time 0 to infinity

Time Frame

0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose

Title

Area under the PF-06700841 and M1 concentration-time curve in mild renal impaired participants

Description

Area under the PF-06700841 and M1 concentration-time curve from time 0 to infinity

Time Frame

0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose

Title

Maximum plasma concentration of PF-06700841 and M1 concentration-time curve in severe renal impaired participants

Description

Maximum plasma concentration of PF-06700841 and M1

Time Frame

0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose

Title

Maximum plasma concentration of PF-06700841 and M1 concentration-time curve in moderate renal impaired participants

Description

Maximum plasma concentration of PF-06700841 and M1

Time Frame

0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose

Title

Maximum plasma concentration of PF-06700841 and M1 concentration-time curve in mild renal impaired participants

Description

Maximum plasma concentration of PF-06700841 and M1

Time Frame

0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose

Secondary Outcome Measure Information:

Title

Number of subjects with treatment-emergent adverse events of PF-06700841

Description

Number of subjects with treatment-emergent adverse events

Time Frame

Screening (Day -28) up to follow-up (Day 35)

Title

Number of subjects with clinically relevant changes in clinical laboratory tests of PF-06700841

Description

Number of subjects with clinical laboratory tests

Time Frame

Screening (Day -28) up to follow-up (Day 35)

Title

Number of subjects with clinically relevant changes in vital signs of PF-06700841

Description

Number of subjects with vital signs

Time Frame

Screening (Day -28) up to follow-up (Day 35)

Title

Number of subjects with clinically relevant changes in physical examination of PF-06700841

Description

Number of subjects with physical examination

Time Frame

Screening (Day -28) up to follow-up (Day 35)

Title

Number of subjects with clinically relevant changes in ECG parameters of PF-06700841

Description

Number of subjects with ECG parameters

Time Frame

Screening (Day -28) up to follow-up (Day 35)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

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

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Facility Name

University of Miami Division of Clinical Pharmacology

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

Facility Name

Prism Research LLC dba Nucleus Network

City

Saint Paul

State/Province

Minnesota

ZIP/Postal Code

55114

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Links:

URL

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

Description

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Renal Impairment Study of PF-06700841

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