A Hepatic Impairment Study for PF-04965842.

Completed · Phase 1

Conditions studied: Hepatic Impairment

In brief

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.

Key facts

Study ID

NCT03626415

Run by

Pfizer

People needed

24

Starts

2018-10-01

Expected to finish

2019-04-30

Last updated by the study team

2020-05-18

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Orlando Clinical Research Center — Orlando, Florida, United States
• Prism Clinical Research, LLC — Saint Paul, Minnesota, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.