A Renal Impairment Study for PF-04965842

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NCT03660241

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Study Location
University of Miami Division of Clinical Pharmacology
Miami, Florida, 33136, United States
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Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

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

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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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

- Breath alcohol test at Screening and Day -1 must be negative.

- 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 on the 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.

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

- Stable concomitant 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 3 months (for example,
those requiring hospitalization, or as judged by the Investigator), evidence of any
infection (including influenza) within the past 7 days prior to baseline, history of
disseminated herpes simplex infection or recurrent or disseminated herpes zoster.


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


- History of or current positive results for human immunodeficiency virus, Hepatitis B,
Hepatitis C.


Additional exclusion criteria for subjects with renal impairment:


- Subjects requiring hemodialysis and peritoneal dialysis.


- Screening BP ≥ 180 mm Hg (systolic) or ≥ 110 mm Hg (diastolic).


- Screening supine 12-lead ECG demonstrating QTcF >470 msec or a QRS interval >120 msec.

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Pfizer Clinical Trials Contact Center

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Renal Impairment Study for PF-04965842
Official Title  ICMJE A PHASE 1, NON-RANDOMIZED, OPEN-LABEL, SINGLE-DOSE STUDY TO EVALUATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF PF-04965842 IN SUBJECTS WITH RENAL IMPAIRMENT AND IN HEALTHY SUBJECTS WITH NORMAL RENAL FUNCTION
Brief Summary This study is a phase 1 non-randomized, open-label, single-dose, parallel-group study of PF 04965842 in subjects with severe renal impairment and subjects without renal impairment (Part 1) and in subjects with moderate renal impairment (Part 2).
Detailed Description This is a Phase 1 non randomized, open label, single dose, parallel cohort, multisite study to investigate the effect of renal impairment on the pharmacokinetics, safety and tolerability of PF-04965842 after a single 200 mg oral dose. 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 approximately16 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 and approximately 8 subjects with moderate renal impairment will be enrolled. The total duration of participation from the Screening Visit to Day 4 will be a maximum of 31 days and from the Screening Visit to Follow-up Contact/Visit will be a maximum of 67 days.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Parallel Assignment
Intervention Model Description:
Part 1 will be conducted. The 8 subjects from the renal impaired group will be recruited before recruiting the 8 subjects without renal impairment function in Part 1. After statistical evaluation of results from Part 1, Part 2 may be conducted.
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Renal Impairment
Intervention  ICMJE Drug: PF-04965842
PF 04965842 is a janus kinase (JAK) 1 inhibitor that is currently being developed for the treatment of atopic dermatitis (AD).
Study Arms  ICMJE Experimental: PF-04965842
PF 04965842 is an oral selevtive janus kinase (JAK) 1 inhibitor
Intervention: Drug: PF-04965842
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 Completed
Actual Enrollment  ICMJE
 (submitted: November 21, 2019)		23
Original Estimated Enrollment  ICMJE
 (submitted: September 4, 2018)		32
Actual Study Completion Date  ICMJE November 5, 2019
Actual Primary Completion Date November 5, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Breath alcohol test at Screening and Day -1 must be negative.
  • 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 on the 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.
  • Any form of renal impairment except acute nephritic syndrome (subjects with history of previous nephritic syndrome but in remission can be included).
  • Stable concomitant drug regimen.

Exclusion Criteria:

  • Renal transplant recipients.
  • Urinary incontinence without catheterization.
  • Subjects with clinically significant infections within the past 3 months (for example, those requiring hospitalization, or as judged by the Investigator), evidence of any infection (including influenza) within the past 7 days prior to baseline, history of disseminated herpes simplex infection or recurrent or disseminated herpes zoster.
  • Subjects with a malignancy or with a history of malignancy, with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
  • History of or current positive results for human immunodeficiency virus, Hepatitis B, Hepatitis C.

Additional exclusion criteria for subjects with renal impairment:

  • Subjects requiring hemodialysis and peritoneal dialysis.
  • Screening BP ? 180 mm Hg (systolic) or ? 110 mm Hg (diastolic).
  • Screening supine 12-lead ECG demonstrating QTcF >470 msec or a QRS interval >120 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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03660241
Other Study ID Numbers  ICMJE B7451021
2018-002865-20 ( EudraCT Number )
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 March 2020

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