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A Renal Impairment Study for PF-06651600

Last updated on August 1, 2019

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Renal Impairment
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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

- Moderate renal impairment (Part 2 only): eGFR >/=30 mL/min and

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT04037865
Pfizer
Not yet recruiting
A Renal Impairment Study for PF-06651600

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now