A Renal Impairment Study for PF-04965842

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-05

Study Completion Date

2019-11-05

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Renal Impairment

Study Design

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Allocation Method

NA

Intervention Model

PARALLEL

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.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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PF-04965842

PF 04965842 is an oral selevtive janus kinase (JAK) 1 inhibitor

Group Type EXPERIMENTAL

PF-04965842

Intervention Type DRUG

PF 04965842 is a janus kinase (JAK) 1 inhibitor that is currently being developed for the treatment of atopic dermatitis (AD).

Interventions

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PF-04965842

PF 04965842 is a janus kinase (JAK) 1 inhibitor that is currently being developed for the treatment of atopic dermatitis (AD).

Intervention Type DRUG

Eligibility Criteria

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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).

* 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.

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes