You are here

A Hepatic Impairment Study for PF-04965842

Last updated on June 4, 2019

FOR MORE INFORMATION
Study Location
University of Miami Division of Clinical Pharmacology
Miami, Florida, 33136 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hepatic 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

- 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

- 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 concomitant drug regimen.

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

- 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.

NCT03660241
Pfizer
Recruiting
A Hepatic Impairment Study for PF-04965842

NEED INFO?

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

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Hepatic Impairment
NCT03660241
All Genders
18+
Years
Multiple Sites
Severe Hepatic Impairment
NCT03865446
All Genders
18+
Years
Multiple Sites

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