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A Hepatic Impairment Study for PF-04965842.

Last updated on August 15, 2018

FOR MORE INFORMATION
Study Location
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
18-70 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 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT03626415
Pfizer
Not yet recruiting
A Hepatic Impairment Study for PF-04965842.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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NCT03626415
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A Hepatic Impairment Study for PF-04965842.
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.
Interventional
Phase 1
Intervention Model: Parallel Assignment
Intervention Model Description:
Recruitment for subjects with moderate and mild hepatic impairment (Cohorts 1 and 2) will initiate first and these subjects will be enrolled in parallel.

Masking: None (Open Label)
Primary Purpose: Basic Science

Hepatic Impairment
Drug: PF-04965842
PF 04965842 is an orally bioavailable small molecule that selectively inhibits JAK1.
Experimental: PF-04965842
PF 04965842 is an orally bioavailable small molecule that selectively inhibits JAK1.
Intervention: Drug: PF-04965842
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
24
Same as current
February 4, 2019
January 5, 2019   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
Yes

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Not Provided
 
 
NCT03626415
B7451020
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2018

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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