Renal Impairment Study of PF-06700841

January 18, 2024 updated by: Pfizer

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami Division of Clinical Pharmacology
      • Miami, Florida, United States, 33136
        • Investigational Drug Services (IDS) University of Miami Hospitals and Clinics, Research Pharmacy
    • Minnesota
      • Saint Paul, Minnesota, United States, 55114
        • Prism Research LLC dba Nucleus Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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
Drug: PF-06700841
A single dose of 30 mg PF-06700841 will be administered on Day 1
Experimental: 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
Drug: PF-06700841
A single dose of 30 mg PF-06700841 will be administered on Day 1
Experimental: 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
Drug: PF-06700841
A single dose of 30 mg PF-06700841 will be administered on Day 1
Experimental: 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
Drug: PF-06700841
A single dose of 30 mg PF-06700841 will be administered on Day 1

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Maximum Observed Plasma Concentration (Cmax) of PF-06700841 Following Single Oral Dose Administration in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function
Time Frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours after dose
Cmax is the maximum observed plasma concentration of PF-06700841 within 72 hours post dose, which was observed directly from the plasma concentration-time data.
Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours after dose
Area Under the Concentration-time Curve From Time 0 to Infinity (AUCinf) of PF-06700841 Following Single Oral Dose Administration in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function
Time Frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours after dose
AUCinf was area under the concentration-time curve from time 0 to infinity, which was calculated for PF-06700841 from the concentration-time data.
Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours after dose
Cmax of PF-06802530 (M1) Following Single Oral Dose Administration in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function
Time Frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours after dose
Cmax is the maximum observed plasma concentration of PF-06802530 (M1), a major metabolite of PF-06700841 within 72 hours post dose, which was observed directly from the plasma concentration-time data.
Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours after dose
AUCinf of PF-06802530 (M1) Following Single Oral Dose Administration in Participants With Renal Impairment and in Healthy Participants With Normal Renal Function
Time Frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours after dose
AUCinf was area under the concentration-time curve from time 0 to infinity, which was calculated for PF-06802530 (M1), a major metabolite of PF-06700841 from the concentration-time data.
Predose, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours after dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time Frame: From screening (Day-28 to Day -2) to up to 35 days after the study treatment (for a period of up to 63 days)
Any events occurring following start of treatment or increasing in severity after the start of the treatment were counted as treatment emergent. An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect. Severe adverse events is an event that prevents normal everyday activities which is a category utilized for rating the intensity of an event.
From screening (Day-28 to Day -2) to up to 35 days after the study treatment (for a period of up to 63 days)
Number of Participants With Laboratory Test Abnormalities Without Regard to Baseline Abnormality
Time Frame: Baseline (Day -1) and Day 4
The hematology, clinical chemistry and urinalysis abnormalities were summarized in accordance with the sponsor reporting standards without regard to baseline abnormality. Baseline is defined as the last planned predose measurement taken on Day -1.
Baseline (Day -1) and Day 4
Number of Participants With Post-baseline Vital Sign Abnormalities
Time Frame: Baseline (Day 1) and Day 4
Vital Signs were assessed against the criteria specified in the sponsor reporting standards for potential clinical concerns. Vital sign abnormalities criteria included: 1) Systolic blood pressure (BP) in millimeters of mercury (mmHg): <90 mmHg with increase or decrease from baseline of ≥30 mmHg with high and low post baseline values; 2) Diastolic blood pressure (BP) (mmHg): <50 mmHg with increase or decrease from baseline of ≥20 mmHg with high and low post baseline values; 3) Supine pulse rate in beats per minutes (bpm): >120 or <40 bpm. Categories with at least 1 participant having vital sign abnormality in any of the reporting arms, were reported in this outcome measure. Baseline is defined as the last planned predose measurement taken on Day 1.
Baseline (Day 1) and Day 4
Number of Participants With Post-baseline Electrocardiogram (ECG) Abnormalities
Time Frame: 0 hr pre-dose and 1-, 3-, and 6-hours post-dose on Day 1; Day 4
ECG abnormalities criteria included: 1) QTc interval adjusted according to Bazett formula (QTcB) in millisecond (msec): > 450, >480, >500, increase from baseline >30, increase from baseline >60; 2) QTc interval adjusted according to Fridericia formula (QTcF) (msec): >450, >480, >500, increase from baseline >30, increase from baseline >60. Categories with at least 1 participant having ECG abnormality in any of the reporting arms, were reported in this outcome measure. Baseline is defined as the last planned predose measurement taken on Day 1.
0 hr pre-dose and 1-, 3-, and 6-hours post-dose on Day 1; Day 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 3, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 4, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 4, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 7, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B7931048

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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