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A Hepatic Impairment Study for PF-04965842

Last updated on November 9, 2018

FOR MORE INFORMATION
Study Location
Orlando Clinical Research Center
Orlando, Florida, 32809 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

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A Hepatic Impairment Study for PF-04965842
A Phase 1, Non-randomized, Open-label, Single-dose Study To Evaluate The Pharmacokinetics, Safety And Tolerability Of Pf-04965842 In Subjects With Renal Impairment And In Healthy Subjects With Normal Renal Function
This study is a phase 1 non-randomized, open-label, single-dose, parallel-group study of PF 04965842 in subjects with severe renal impairment and subjects without renal impairment (Part 1) and in subjects with mild and moderate renal impairment (Part 2).
This is a Phase 1 non randomized, open label, single dose, parallel cohort, multisite study to investigate the effect of renal impairment on the pharmacokinetics, safety and tolerability of PF-04965842 after a single 200 mg oral dose. Subjects will be selected and categorized into normal renal function or renal impairment groups based on their estimated glomerular filtration rate. Part 1: A total of approximately16 subjects will be enrolled; approximately 8 subjects with severe renal impairment and approximately 8 with normal renal function. After statistical evaluation of results from Part 1, Part 2 may be conducted and approximately 8 subjects each with moderate and mild renal impairment will be enrolled. The total duration of participation from the Screening Visit to Day 4 will be a maximum of 31 days and from the Screening Visit to Follow-up Contact/Visit will be a maximum of 67 days.
Interventional
Phase 1
Intervention Model: Parallel Assignment
Intervention Model Description:
Part 1 will be conducted. The 8 subjects from the renal impaired group will be recruited before recruiting the 8 subjects without renal impairment function in Part 1. After statistical evaluation of results from Part 1, Part 2 may be conducted.

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

Hepatic Impairment
Drug: PF-04965842
PF 04965842 is a janus kinase (JAK) 1 inhibitor that is currently being developed for the treatment of atopic dermatitis (AD).
Experimental: PF-04965842
PF 04965842 is an oral selevtive janus kinase (JAK) 1 inhibitor
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
32
Same as current
March 8, 2020
February 6, 2020   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 <30 mL/min, but not requiring hemodialysis.
    • Moderate renal impairment (Part 2 only): eGFR ?30 mL/min and <60 mL/min.
    • 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:

  • 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.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
Yes

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Not Provided
 
 
NCT03660241
B7451021
2018-002865-20 ( EudraCT Number )
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
August 2018

ICMJE     Data element required by the

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

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