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A Renal Impairment Study for PF-06651600

Primary Purpose

Renal Impairment

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PF-06651600
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Renal Impairment

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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 <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

Sites / Locations

  • Investigational Drug Services (IDS) University of Miami Hospitals and Clinics
  • University of Miami Division of Clinical Pharmacology
  • Prism Clinical Research, LLC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

PF-06651600 Severe Renal Impairment

PF-06651600 Normal Renal Function

PF-06651600 Moderate Renal Impairment

PF-06651600 Mild Renal Impairment

Arm Description

This arm includes participants with severe renal impairment who will receive oral doses of PF-06651600 50 mg on Day 1 through Day 10

This arm includes participants with normal renal function who will receive oral doses of PF-06651600 50 mg on Day 1 through Day 10

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

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.

Outcomes

Primary Outcome Measures

Plasma PF-06651600 Maximum Plasma Concentration (Cmax)
The plasma PF-06651600 Cmax was observed directly from data.
Plasma PF-06651600 Area Under the Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24)
Plasma PF-06651600 AUC0-24 was determined using a linear/log trapezoidal method.

Secondary Outcome Measures

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE is considered a TEAE is the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the last dose plus the lag time were flagged as TEAEs. An AE was considered treatment-related if the causality of the AE was assessed to be the investigational product. The causality of AEs was assessed by the investigator using clinical judgment.
Number of Participants With Laboratory Abnormalities
Safety laboratory assessments include clinical chemistry, hematology and urinalysis. Serum creatinine was only assessed on Screening visit 2 and on Day 2 and Day 8 for eGFR assessment. The number of participants with laboratory test abnormalities without regard to baseline abnormality was reported.
Number of Participants With Vital Signs Data Meeting Pre-specified Criteria
Vital signs evaluations included supine blood pressure (BP), pulse rate, and temperature. Criteria for vital signs values included: supine diastolic BP >= 20 mmHg increase from baseline, supine systolic BP >= 30 mmHg increase from baseline, supine diastolic BP >= 20 mmHg decrease from baseline, and supine systolic BP >= 30 mmHg decrease from baseline.
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria
ECG criteria included PR, QT, and QTc intervals and QRS complex. Participants with absolute data value meeting the following criteria were reported: aggregate PR interval value >= 300 msec, aggregate QRS duration value >= 140 msec, absolute QTcF interval value >450 msec and <= 480 msec, or >480 msec and <=500 msec, or >500 msec.

Full Information

First Posted
July 26, 2019
Last Updated
April 27, 2021
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT04037865
Brief Title
A Renal Impairment Study for PF-06651600
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated due to extensive Covid-19 delay.
Study Start Date
August 19, 2019 (Actual)
Primary Completion Date
March 31, 2020 (Actual)
Study Completion Date
March 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This 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 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-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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Impairment

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PF-06651600 Severe Renal Impairment
Arm Type
Experimental
Arm Description
This arm includes participants with severe renal impairment who will receive oral doses of PF-06651600 50 mg on Day 1 through Day 10
Arm Title
PF-06651600 Normal Renal Function
Arm Type
Experimental
Arm Description
This arm includes participants with normal renal function who will receive oral doses of PF-06651600 50 mg on Day 1 through Day 10
Arm Title
PF-06651600 Moderate Renal Impairment
Arm Type
Experimental
Arm Description
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
Arm Title
PF-06651600 Mild Renal Impairment
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
PF-06651600
Intervention Description
PF-06651600 50 mg oral tablets will be administered on Days 1 to 10
Primary Outcome Measure Information:
Title
Plasma PF-06651600 Maximum Plasma Concentration (Cmax)
Description
The plasma PF-06651600 Cmax was observed directly from data.
Time Frame
On Day 8 and Day 9 predose, and at 0 (predose), 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16 hours after dose on Day 10, and 24 hours after dose on Day 11.
Title
Plasma PF-06651600 Area Under the Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24)
Description
Plasma PF-06651600 AUC0-24 was determined using a linear/log trapezoidal method.
Time Frame
On Day 8 and Day 9 predose, and at 0 (predose), 0.25, 0.5, 1, 2, 4, 6, 8, 12, 16 hours after dose on Day 10, and 24 hours after dose on Day 11.
Secondary Outcome Measure Information:
Title
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Description
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE is considered a TEAE is the event started during the effective duration of treatment. All events that started on or after the first dosing day and time/start time, if collected, but before the last dose plus the lag time were flagged as TEAEs. An AE was considered treatment-related if the causality of the AE was assessed to be the investigational product. The causality of AEs was assessed by the investigator using clinical judgment.
Time Frame
From Screening (Day -28) through and including up to 35 calendar days after the last administration of investigational product, assessed up to 74 days.
Title
Number of Participants With Laboratory Abnormalities
Description
Safety laboratory assessments include clinical chemistry, hematology and urinalysis. Serum creatinine was only assessed on Screening visit 2 and on Day 2 and Day 8 for eGFR assessment. The number of participants with laboratory test abnormalities without regard to baseline abnormality was reported.
Time Frame
At Screening Visit 1 and on Days -1, 5, 11 and early termination day.
Title
Number of Participants With Vital Signs Data Meeting Pre-specified Criteria
Description
Vital signs evaluations included supine blood pressure (BP), pulse rate, and temperature. Criteria for vital signs values included: supine diastolic BP >= 20 mmHg increase from baseline, supine systolic BP >= 30 mmHg increase from baseline, supine diastolic BP >= 20 mmHg decrease from baseline, and supine systolic BP >= 30 mmHg decrease from baseline.
Time Frame
At screening, on Day 1, Day 5, Day 11 and early termination/discontinuation.
Title
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria
Description
ECG criteria included PR, QT, and QTc intervals and QRS complex. Participants with absolute data value meeting the following criteria were reported: aggregate PR interval value >= 300 msec, aggregate QRS duration value >= 140 msec, absolute QTcF interval value >450 msec and <= 480 msec, or >480 msec and <=500 msec, or >500 msec.
Time Frame
At screening, on Day -1, Day 11 and early termination/discontinuation.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 <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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Drug Services (IDS) University of Miami Hospitals and Clinics
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
University of Miami Division of Clinical Pharmacology
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Prism Clinical Research, LLC
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=B7981020
Description
To obtain contact information for a study center near you, click here.

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A Renal Impairment Study for PF-06651600

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