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Glasdegib Renal Impairment Study

NCT03596567 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2019-08-29

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-17
Primary Completion
2018-08-28
Completion
2018-09-19
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03596567 on ClinicalTrials.gov