A Hepatic Impairment Study for PF-04965842



Status:Recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 75
Updated:3/17/2019
Start Date:October 5, 2018
End Date:March 2020
Contact:Pfizer CT.gov Call Center
Email:ClinicalTrials.gov_Inquiries@pfizer.com
Phone:1-800-718-1021

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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

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 mild and moderate renal impairment (Part 2).

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 each with moderate and mild 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.

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.

- 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 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, 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.
We found this trial at
4
sites
1475 NW 12th Ave
Miami, Florida 33136
(305) 243-1000
University of Miami, Sylvester Comprehensive Cancer Center Sylvester Comprehensive Cancer Center integrates all cancer-related activities...
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5055 South Orange Ave Orlando FL 32909
Orlando, Florida 32806
407-240-7878
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