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A Renal Impairment Study for PF-04965842

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03660241
Recruitment Status : Completed
First Posted : September 6, 2018
Last Update Posted : March 23, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

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).

Condition or disease Intervention/treatment Phase
Renal Impairment Drug: PF-04965842 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
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
Official Title: 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
Actual Study Start Date : October 5, 2018
Actual Primary Completion Date : November 5, 2019
Actual Study Completion Date : November 5, 2019

Arm Intervention/treatment
Experimental: PF-04965842
PF 04965842 is an oral selevtive janus kinase (JAK) 1 inhibitor
Drug: PF-04965842
PF 04965842 is a janus kinase (JAK) 1 inhibitor that is currently being developed for the treatment of atopic dermatitis (AD).




Primary Outcome Measures :
  1. Area under the concentration-time curve of PF-04965842 and its active metabolites PF-06471658 and PF-07055087 [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours post-dose ]
    Area under the concentration-time profile (AUC inf) from time zero extrapolated to infinity for PF-04965842 and its active metabolites PF-06471658 and PF-07055087.

  2. Maximum serum concentration of PF-04965842 and its active metabolites PF-06471658 and PF-07055087 [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72 hours post-dose ]
    Maximum serum concentration (C max) of PF-04965842 and its active metabolites PF-06471658 and PF-07055087


Secondary Outcome Measures :
  1. Adverse events of PF-04965842 [ Time Frame: Screening (Day -28) up to follow up (Day 36) ]
    Number of subjects with adverse events (AEs)

  2. Clinically relevant abnormal vital signs of PF-04965842 [ Time Frame: Screening (Day -28) up to Day 4 ]
    Number of subjects with clinically relevant changes in vital signs

  3. Clinically relevant abnormal laboratory findings of PF-04965842 [ Time Frame: Screening (Day -28) up to Day 4 ]
    Number of subjects with clinically relevant changes in laboratory findings.

  4. Clinically relevant abnormal physical exam findings of PF-04965842 [ Time Frame: Screening (Day -28) up to Day 4 ]
    Number of subjects with clinically relevant changes in physical exam



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03660241


Locations
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United States, Florida
University of Miami Division of Clinical Pharmacology
Miami, Florida, United States, 33136
University of Miami, Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
Belgium
Brussels Clinical Research Unit
Brussels, Be-bru, Belgium, B-1070
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT03660241    
Other Study ID Numbers: B7451021
2018-002865-20 ( EudraCT Number )
First Posted: September 6, 2018    Key Record Dates
Last Update Posted: March 23, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
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/data_requests.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases