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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04037865
Other study ID # B7981020
Secondary ID
Status Terminated
Phase Phase 1
First received
Last updated
Start date August 19, 2019
Est. completion date March 31, 2020

Study information

Verified date April 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Terminated
Enrollment 8
Est. completion date March 31, 2020
Est. primary completion date March 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
PF-06651600
PF-06651600 50 mg oral tablets will be administered on Days 1 to 10

Locations

Country Name City State
United States Investigational Drug Services (IDS) University of Miami Hospitals and Clinics Miami Florida
United States University of Miami Division of Clinical Pharmacology Miami Florida
United States Prism Clinical Research, LLC Saint Paul Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Plasma PF-06651600 Maximum Plasma Concentration (Cmax) The plasma PF-06651600 Cmax was observed directly from data. 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.
Primary 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. 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 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. From Screening (Day -28) through and including up to 35 calendar days after the last administration of investigational product, assessed up to 74 days.
Secondary 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. At Screening Visit 1 and on Days -1, 5, 11 and early termination day.
Secondary 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. At screening, on Day 1, Day 5, Day 11 and early termination/discontinuation.
Secondary 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. At screening, on Day -1, Day 11 and early termination/discontinuation.
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