NCT03627754

A Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of Glasdegib

A PHASE 1, OPEN LABEL, SINGLE DOSE, PARALLEL GROUP STUDY TO EVALUATE THE PLASMA PHARMACOKINETICS OF GLASDEGIB (PF-04449913) IN HEALTHY SUBJECTS WITH NORMAL HEPATIC FUNCTION AND IN SUBJECTS WITH IMPAIRED HEPATIC FUNCTION

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1, open-label, parallel group, single dose study to investigate the effect of moderate or severe hepatic impairment on the PK of glasdegib, compared to subjects with normal hepatic function.

Detailed description

This is a Phase 1, open-label, parallel group, single dose study to investigate the effect of hepatic impairment on the PK of glasdegib after administration of a single oral 100 mg dose. Subjects with moderate or severe hepatic impairment will be enrolled, followed by healthy subjects with normal hepatic function who serve as matched controls.

Conditions

• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	Glasdegib 100 mg single oral dose	A single dose of 100 mg glasdegib tablet will be administered after an overnight fast, followed by serial PK collection, discharge and follow-up.

Timeline

• Start date: 2018-11-05
• Primary completion: 2019-04-11
• Completion: 2019-04-11
• First posted: 2018-08-13
• Last updated: 2019-05-06

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study