NCT03270878

Glasdegib Absolute Bioavailability Study

A Phase One, Single Dose, Randomized, Open-label, Two-period, Two-sequence, Crossover, Absolute Bioavailability Study Of Glasdegib (Pf-04449913) In Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study is intended to estimate the absolute bioavailability of Glasdegib by comparison of the pharmacokinetic exposures following administration of an oral, single dose 100 mg tablet vs. an IV infusion of a 50 mg IV dose in the fasted state in a crossover fashion to healthy volunteers.

Conditions

• Healthy Volunteer Study

Interventions

Type	Name	Description
DRUG	Glasdegib Oral Tablet	Subjects will receive a single 100 mg oral tablet of glasdegib under fasted conditions, either in study period 1 or 2, depending on randomization.
DRUG	Glasdegib IV infusion	Subjects will receive a 50 mg IV infusion of glasdegib over approximately 1.25 hours, in the fasted state, in either period 1 or 2 based on randomization.

Timeline

• Start date: 2017-09-07
• Primary completion: 2017-10-06
• Completion: 2017-10-30
• First posted: 2017-09-01
• Last updated: 2017-11-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study