NCT03596567

Glasdegib Renal Impairment Study

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

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

Summary

The goal of this study is to administer single dose (100 mg) glasdegib tablet to subjects with normal, moderate and severe renal impairment and estimate the effect, if any, of this renal impairment on glasdegib pharmacokinetics.

Conditions

• Renal Impairment

Interventions

Type	Name	Description
DRUG	Glasdegib single 100 mg dose in normal healthy subjects	A single dose of 100 mg glasdegib tablet will be administered after an overnight fast, followed by serial PK collection, discharge and follow -up.
DRUG	Glasdegib single 100 mg dose in moderate renal impairment subjects	A single dose of 100 mg glasdegib tablet will be administered to subjects with moderate renal impairment, after an overnight fast, followed by serial PK collection, discharge and follow -up.
DRUG	Glasdegib single 100 mg dose in severe renal impairment subjects	A single dose of 100 mg glasdegib tablet will be administered to subjects with severe renal impairment, after an overnight fast, followed by serial PK collection, discharge and follow -up.

Timeline

• Start date: 2018-05-17
• Primary completion: 2018-08-28
• Completion: 2018-09-19
• First posted: 2018-07-24
• Last updated: 2019-08-29

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study