NCT03309202

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

Hepatic impairment PK study

Detailed description

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

• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	PF-05221304	25 mg dose

Timeline

• Start date: 2017-12-19
• Primary completion: 2018-06-26
• Completion: 2018-07-18
• First posted: 2017-10-13
• Last updated: 2019-08-08
• Results posted: 2019-08-08

Locations

6 sites across 4 countries: United States, Belgium, Czechia, Slovakia

Regulatory

• FDA-regulated drug study