A Hepatic Impairment Study for PF-04965842.



Status:Recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 70
Updated:3/17/2019
Start Date:October 1, 2018
End Date:May 2019
Contact:Pfizer CT.gov Call Center
Email:ClinicalTrials.gov_Inquiries@pfizer.com
Phone:1-800-718-1021

Use our guide to learn which trials are right for you!

A PHASE 1, NON-RANDOMIZED, OPEN-LABEL, SINGLE-DOSE STUDY TO COMPARE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF PF-04965842 IN ADULT SUBJECTS WITH MILD AND MODERATE HEPATIC IMPAIRMENT RELATIVE TO SUBJECTS WITH NORMAL HEPATIC FUNCTION

This is a Phase 1 non randomized, open label, single dose, parallel cohort study to
investigate the effect of hepatic impairment on the PK, safety and tolerability of PF
04965842.

A minimum of 24 subjects with normal, mild or moderate hepatic function will be enrolled into
the study, with approximately 8 subjects in each cohort. The Child Pugh classification score
will be utilized to assess entry criteria and to assign subjects into the appropriate hepatic
impairment group. For individual subjects, the total maximum duration of study participation
from the Screening visit to the end of clinical research unit (CRU) stay is approximately 31
days and approximately 63 days from the Screening visit to the Follow up contact.

Inclusion Criteria:

- Body mass index (BMI) of 17.5 to 40 kg/m2; and a total body weight >50 kg (110
pounds).

- Subjects who are willing and able to comply with all scheduled visits, treatment plan,
laboratory tests, and other study procedures.

Additional Inclusion Criteria for subjects with hepatic impairment:

- Satisfy the criteria for Class A or Class B of the Child Pugh classification (mild:
Child Pugh Scores 5 to 6 points, and moderate: Child Pugh Scores 7 to 9 points),
within 14 days of investigational product administration.

- A diagnosis of hepatic dysfunction due to hepatocellular disease (and not secondary to
any acute ongoing hepatocellular process) documented by medical history, physical
examination, liver biopsy, hepatic ultrasound, computerized tomography scan, or
magnetic resonance imaging (MRI).

Exclusion Criteria:

- 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 (>1 episode) 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.

Additional exclusion criteria for subjects with hepatic impairment:

- Hepatic carcinoma or hepatorenal syndrome or limited predicted life expectancy
(defined as less than 1 year).

- Subjects who have previously had a transplanted kidney, liver, or heart.

- At Screening, persistent severe, uncontrolled hypertension.
We found this trial at
2
sites
5055 South Orange Ave Orlando FL 32909
Orlando, Florida 32806
407-240-7878
?
mi
from
Orlando, FL
Click here to add this to my saved trials
1000 Westgate Drive
Saint Paul, Minnesota 55114
?
mi
from
Saint Paul, MN
Click here to add this to my saved trials