NCT03626415

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

• 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

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.

Detailed description

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.

Conditions

• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	PF-04965842	PF 04965842 is an orally bioavailable small molecule that selectively inhibits JAK1.

Timeline

• Start date: 2018-10-01
• Primary completion: 2019-04-30
• Completion: 2019-04-30
• First posted: 2018-08-13
• Last updated: 2020-05-18
• Results posted: 2020-05-18

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study