A Study Of Glasdegib In Healthy Volunteers To Establish The Bioequivalence Of The Phase 2 Formulation To The ICH Formulation

Healthy Volunteers Clinical Trial

— B1371026  

Official title:

A Phase 1, Randomized, Open-label Study Of Glasdegib (Pf-04449913) In Healthy Volunteers To Establish The Bioequivalence Of The Phase 2 Formulation To The Glasdegib Ich Formulation And To Estimate The Potential Effect Of Food And A Proton Pump Inhibitor On Glasdegib Plasma Pharmacokinetics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03130556
• Other study ID #: B1371026
• Status: Completed
• Phase: Phase 1
• First received: April 21, 2017
• Last updated: July 28, 2017
• Start date: May 1, 2017
• Est. completion date: July 21, 2017

Study information

• Verified date: July 2017
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is intended to establish the bioequivalence (BE) of single 100 mg doses of glasdegib administered under fasted conditions to healthy volunteers as the ICH formulation compared to the Phase 2 formulation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 21, 2017
• Est. primary completion date: July 6, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy male and/or female subjects of non-child bearing potential who, at the time of screening, are between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG or clinical laboratory tests. Female subjects of nonchildbearing potential must meet at least 1 of the following criteria:

1. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 24 consecutive months with no alternative pathological or physiological cause; with a serum follicle-stimulating hormone (FSH) level confirming the postmenopausal state;

2. Have undergone a documented hysterectomy and/or bilateral oophorectomy;

3. Have medically confirmed ovarian failure. All other female subjects (including females with tubal ligations and females that do NOT have a documented hysterectomy, bilateral oophorectomy and/or ovarian failure) are considered to be of childbearing potential.

• Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).

• Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study. -. Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

• A positive urine drug test.

• Screening supine 12-lead ECG demonstrating a corrected QT (QTc) interval >450 msec or a QRS interval >120 msec. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTc or QRS values should be used to determine the subject's eligibility.

• Subjects with family history of myocardial infarction, congenital long QT syndrome, torsades de pointes or clinically significant ventricular arrhythmias. Subjects should be within normal range of potassium, magnesium and corrected calcium calculation at screening.

• Pregnant female subjects; breastfeeding female subjects; female subjects of childbearing potential; male subjects with partners currently pregnant; male subjects who are unwilling or unable to use two highly effective methods of contraception as outlined in this protocol for the duration of the study and for at least 90 days after the last dose of investigational product and, refrain from sperm donation for the duration of the Study and for at least 90 days after the last dose of investigational product.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Glasdegib
Subjects receive 100 mg single dose of ICH glasdegib under fasted condition with washout and then 100 mg single dose of Phase 2 tablet under fasted condition with washout in a randomized fashion. Finally subjects either receive a 100 mg single dose ICH tablet after a high fat, high calorie meal or receive a 100 mg single dose of ICH tablet after repeated daily dosing with rabeprazole.

Other:
• High Fat, High Calorie Meal
A subset of subjects in the study will receive a high fat, high calorie meal prior to being administered a single 100 mg tablet ICH tablet of glasdegib.

Drug:
• Rabeprazole
A subset of subjects will receive repeated daily dosing of 40 mg rabeprazole for 7 days with 100 mg single dose of ICH glasdegib being administered on Day 7.

Locations

Country	Name	City	State
United States	Pfizer New Haven Clinical Research Unit	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration (Cmax)		5 days
Primary	Area Under the Curve From Time Zero to Last Measured Time Point [AUC (0 - t)]		5 days
Secondary	Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]		5 days

External Links

•   To obtain contact information for a study center near you, click here.