Renal Impairment Study of PF-06700841

NCT04260464

Last updated date
Study Location
Investigational Drug Services (IDS) University of Miami Hospitals and Clinics, Research Pharmacy
Miami, Florida, 33136, United States
Contact
1-800-718-1021

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Volunteer, Renal Impairment
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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).

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Healthy Volunteer, Renal ImpairmentRenal Impairment Study of PF-06700841 NCT04260464
  1. Miami, Florida
  2. Miami, Florida
  3. Saint Paul, Minnesota
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Renal Impairment Study of PF-06700841
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Single group
Masking: None (Open Label)
Masking Description:
No Masking
Primary Purpose: Other
Condition  ICMJE
  • Healthy Volunteer
  • Renal Impairment
Intervention  ICMJE Drug: PF-06700841
A single dose of 30 mg PF-06700841 will be administered on Day 1
Study Arms  ICMJE
  • 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
    Intervention: Drug: PF-06700841
  • 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
    Intervention: Drug: PF-06700841
  • 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
    Intervention: Drug: PF-06700841
  • 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
    Intervention: Drug: PF-06700841
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 5, 2020)
32
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 12, 2021
Estimated Primary Completion Date July 12, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04260464
Other Study ID Numbers  ICMJE B7931048
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
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/d….
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP