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Study of PF-05221304 in Subjects With Varying Degrees of Hepatic Impairment

Last updated on March 31, 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
18-70 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

All subjects -

- Adults 70 years of age

- BMI 35.4 kg/m2

- HIV positive

- Conditions that affect drug absorption

- Positive breath alcohol test

Healthy/ those without hepatic impairment -

- Known or suspected hepatic impairment

- Evidence of Hepatitis B or C

- On any chronic medications

Those with varying degrees of hepatic impairment -

- Not meeting Classification A, B, or C of hepatic impairment based on Child-Pugh
Classification

- Evidence of Hepatic carcinoma or hepatorenal syndrome or limited predicted life
expectancy

- Recent GI bleed

- Moderate or severe renal impairment

- Hepatic encephalopathy Grade 3 or higher

NCT03309202
Pfizer
Recruiting
Study of PF-05221304 in Subjects With Varying Degrees of Hepatic Impairment

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Study of PF-05221304 in Subjects With Varying Degrees of Hepatic Impairment
A Phase 1, Non-randomized, Open-label, Single-dose, Parallel Cohort Study To Compare The Pharmacokinetics Of Pf-05221304 In Adult Subjects With Varying Degrees Of Hepatic Impairment Relative To Subjects Without Hepatic Impairment
Hepatic impairment PK study
This is a non randomized, open label, single dose, parallel cohort, multisite study to investigate the effect of varying degrees of hepatic impairment on the plasma pharmacokinetics (total and unbound) of PF-05221304 after a single oral dose administered in the fed state.
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Hepatic Impairment
Drug: PF-05221304
25 mg dose
Other Name: experimental drug
  • Experimental: Cohort 1_Without impairment
    Single, 25 mg dose of PF-05221304
    Intervention: Drug: PF-05221304
  • Experimental: Cohort 2_Mild impairment
    Single, 25 mg dose of PF-05221304
    Intervention: Drug: PF-05221304
  • Experimental: Cohort 3_Moderate impairment
    Single, 25 mg dose of PF-05221304
    Intervention: Drug: PF-05221304
  • Experimental: Cohort 4_Severe impairment
    Single, 25 mg dose of PF-05221304
    Intervention: Drug: PF-05221304
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
November 22, 2018
November 22, 2018   (Final data collection date for primary outcome measure)

Key Exclusion Criteria:

All subjects -

  • Adults <18 years of age and >70 years of age
  • BMI < 17.5 and > 35.4 kg/m2
  • HIV positive
  • Conditions that affect drug absorption
  • Positive breath alcohol test

Healthy/ those without hepatic impairment -

  • Known or suspected hepatic impairment
  • Evidence of Hepatitis B or C
  • On any chronic medications

Those with varying degrees of hepatic impairment -

  • Not meeting Classification A, B, or C of hepatic impairment based on Child-Pugh Classification
  • Evidence of Hepatic carcinoma or hepatorenal syndrome or limited predicted life expectancy
  • Recent GI bleed
  • Moderate or severe renal impairment
  • Hepatic encephalopathy Grade 3 or higher
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
Yes

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Belgium
Czechia,   Slovakia,   United States
 
NCT03309202
C1171006
2017-003034-86 ( 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
November 2017

ICMJE     Data element required by the

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

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