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A Renal Impairment Study for PF-06651600

Last updated on November 19, 2019

FOR MORE INFORMATION
Study Location
Investigational Drug Services (IDS) University of Miami Hospitals and Clinics
Miami, Florida, 33136 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
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

- Body mass index (BMI) of >/= 17.5 to = 40.0 kg/m2; and a total body weight > 50 kg
(110 lb)

Additional inclusion criteria for subjects with renal impairment:

- Meet the following eGFR criteria during the screening period based upon MDRD equation:

- Severe renal impairment: eGFR

- Moderate renal impairment (Part 2 only): eGFR >/=30 mL/min and

- Mild renal impairment (Part 2 only): eGFR between 60 and 89 mL/min

- Any form of renal impairment except acute nephritic syndrome (subjects with history of
previous nephritic syndrome but in remission can be included)

- Stable drug regimen

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

- Females of child-bearing potential must use an accepted, highly effective
contraceptive method

- 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, history of disseminated herpes simplex or recurrent or
disseminated herpes zoster

- Subjects with malignancy or with a history of malignancy, with the exception of
adequately treated or excised non-metastatic basal cell or squamous cell cancer of
skin or cervical carcinoma in situ

- HIV, Hepatitis B, or Hepatitis C infection

Additional exclusion criteria for subjects with renal impairment:

- Subjects requiring hemodialysis and peritoneal dialysis

- Screening BP >/=180 mmHg (systolic) or >/=110 mmHg (diastolic)

- Screening 12-lead ECG demonstrating QTcF >470 msec

NCT04037865
Pfizer
Recruiting
A Renal Impairment Study for PF-06651600

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[email protected]

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Descriptive Information
Brief Title  ICMJE A Renal Impairment Study for PF-06651600
Official Title  ICMJE A PHASE 1, NON-RANDOMIZED, OPEN LABEL, MULTIPLE DOSE STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF PF 06651600 IN PARTICIPANTS WITH RENAL IMPAIRMENT AND IN HEALTHY PARTICIPANTS WITH NORMAL RENAL FUNCTION
Brief SummaryThis is a Phase 1 non-randomized, open-label, parallel cohort study of PF-06651600 in subjects with severe renal impairment and subjects without renal impairment (Part 1) and in subjects with mild and moderate renal impairment (Part 2).
Detailed DescriptionThis 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-06651600 after multiple oral doses of 50 mg daily. 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 11 will be a maximum of 39 days and from Screening visit to Follow-up/Contact Visit will a maximum of 73 days.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Renal Impairment
Intervention  ICMJE Drug: PF-06651600
PF-06651600 50 mg oral tablets will be administered on Days 1 to 10
Study Arms  ICMJE
  • Experimental: PF-06651600 Severe Renal Impairment
    This arm includes participants with severe renal impairment who will receive oral doses of PF-06651600 50 mg on Day 1 through Day 10
    Intervention: Drug: PF-06651600
  • Experimental: PF-06651600 Normal Renal Function
    This arm includes participants with normal renal function who will receive oral doses of PF-06651600 50 mg on Day 1 through Day 10
    Intervention: Drug: PF-06651600
  • Experimental: PF-06651600 Moderate Renal Impairment
    This arm is in Part 2 which will be conducted if decision criterion to proceed to Part 2 is met. This arm includes participants with moderate renal impairment who will receive oral doses of PF-06651600 50 mg on Day 1 through Day 10
    Intervention: Drug: PF-06651600
  • Experimental: PF-06651600 Mild Renal Impairment
    This arm is in Part 2 which will be conducted if the decision criterion to proceed to Part 2 is met. The arm includes participants with mild renal impairment who will receive oral doses of PF-06651600 50 mg on Day 1 through Day 10.
    Intervention: Drug: PF-06651600
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: July 26, 2019)
32
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 15, 2020
Estimated Primary Completion DateOctober 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Body mass index (BMI) of >/= 17.5 to 50 kg (110 lb)

Additional inclusion criteria for subjects with renal impairment:

  • Meet the following eGFR criteria during the screening period based upon MDRD equation:
  • Severe renal impairment: eGFR <30 mL/min but not requiring hemodialysis
  • Moderate renal impairment (Part 2 only): eGFR >/=30 mL/min and <60 mL/min
  • Mild renal impairment (Part 2 only): eGFR between 60 and 89 mL/min
  • Any form of renal impairment except acute nephritic syndrome (subjects with history of previous nephritic syndrome but in remission can be included)
  • Stable drug regimen

Exclusion Criteria:

  • Females of child-bearing potential must use an accepted, highly effective contraceptive method
  • 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, history of disseminated herpes simplex or recurrent or disseminated herpes zoster
  • Subjects with malignancy or with a history of malignancy, with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of skin or cervical carcinoma in situ
  • HIV, Hepatitis B, or Hepatitis C infection

Additional exclusion criteria for subjects with renal impairment:

  • Subjects requiring hemodialysis and peritoneal dialysis
  • Screening BP >/=180 mmHg (systolic) or >/=110 mmHg (diastolic)
  • Screening 12-lead ECG demonstrating QTcF >470 msec
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 NCT04037865
Other Study ID Numbers  ICMJE B7981020
Has Data Monitoring CommitteeNot Provided
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/da....
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateOctober 2019

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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