Glasdegib Renal Impairment Study

PHASE1CompletedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

May 17, 2018

Primary Completion Date

August 28, 2018

Study Completion Date

September 19, 2018

Conditions
Renal Impairment
Interventions
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.

Trial Locations (3)

33136

University of Miami Division of Clinical Pharmacology, Miami

University of Miami, Sylvester Comprehensive Cancer Center, Miami

55114

Prism Clinical Research LLC, Saint Paul

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY