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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-19

Study Completion Date

2018-07-18

Brief Summary

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Hepatic impairment PK study

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Detailed Description

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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.

Conditions

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Hepatic Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Cohort 1_Without impairment

Single, 25 mg dose of PF-05221304

Group Type EXPERIMENTAL

PF-05221304

Intervention Type DRUG

25 mg dose

Cohort 2_Mild impairment

Single, 25 mg dose of PF-05221304

Group Type EXPERIMENTAL

PF-05221304

Intervention Type DRUG

25 mg dose

Cohort 3_Moderate impairment

Single, 25 mg dose of PF-05221304

Group Type EXPERIMENTAL

PF-05221304

Intervention Type DRUG

25 mg dose

Cohort 4_Severe impairment

Single, 25 mg dose of PF-05221304

Group Type EXPERIMENTAL

PF-05221304

Intervention Type DRUG

25 mg dose

Interventions

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PF-05221304

25 mg dose

Intervention Type DRUG

Other Intervention Names

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experimental drug

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes