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A Phase 1 Study To Evaluate The Effect Of Glasdegib On The Cardiac Repolarization In Healthy Subjects

Last updated on November 20, 2019

FOR MORE INFORMATION
Study Location
Pfizer Clinical Research Unit
Brussels, , B-1070 Belgium
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Volunteers
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 1. 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 12 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.

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

3. Evidence of a personally signed and dated informed consent document indicating
that the subject has been informed of all pertinent aspects of the study.

4. Subjects who are willing and able to comply with all scheduled visits, treatment
plan, laboratory tests, and other study procedures.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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 atleast one 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.

History of known QTc prolongation or ECG abnormalities.

Self-reported history of risk factors for QT prolongation or torsades de pointes (eg,
organic heart disease, congestive heart failure, hypokalemia,
hypomagnesemia,congenital long QT syndrome, myocardial ischemia or infarction,
congenital deafness, and family history of sudden death, or a family history of
congenital QT syndrome).

Self-reported history of sick sinus syndrome, first, second, or third degree
atrioventricular (AV) block, myocardial infarction, pulmonary congestion, cardiac
arrhythmia, prolonged QT interval or conduction abnormalities, or any other
clinically significant cardiovascular disease history.

NCT03162900
Pfizer
Not yet recruiting
A Phase 1 Study To Evaluate The Effect Of Glasdegib On The Cardiac Repolarization In Healthy Subjects

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Pfizer Clinical Trials Contact Center

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[email protected]

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Descriptive Information
Brief Title  ICMJE A Phase 1 Study To Evaluate The Effect Of Glasdegib On The Cardiac Repolarization In Healthy Subjects
Official Title  ICMJE A PHASE 1, SINGLE CENTER, RANDOMIZED, 4-WAY CROSSOVER, DOUBLE BLINDED, PLACEBO AND MOXIFLOXACIN CONTROLLED STUDY TO EVALUATE THE EFFECT OF GLASDEGIB ON THE CARDIAC REPOLARIZATION IN HEALTHY SUBJECTS
Brief SummaryThis is a Thorough QT study intended to estimate the effect of glasdegib at therapeutic exposure and at supra-therapeutic exposure on cardiac repolarization in healthy subjects. This is a randomized, double blind, positive and placebo controlled study with a 6 day washout between successive periods.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Drug: Glasdegib Therapeutic Exposure
    Subjects Receive a single 150 mg dose of Glasdegib followed by ECG and PK assessments.
  • Drug: Glasdegib Supra-therapeutic Exposure
    Subjects receive a single 300 mg dose of glasdegib followed by ECG and PK assessments.
  • Drug: Positive Control (Moxifloxacin)
    Subjects will receive a single 400 mg dose of moxifloxacin followed by ECG and PK assessments.
  • Other: Placebo Control
    Subjects will receive placebo dose followed by ECG and PK assessments.
Study Arms  ICMJE
  • Experimental: Glasdegib QT Therapeutic Exposure
    Randomized sequence of Glasdegib clinical exposure, Placebo and moxifloxacin active control administration. This treatment will be in four separate sequences with four periods per sequence. Each period will be separated by a washout of atleast 6 days.
    Interventions:
    • Drug: Glasdegib Therapeutic Exposure
    • Drug: Positive Control (Moxifloxacin)
    • Other: Placebo Control
  • Experimental: Glasdegib QT Supra-therapeutic Exposure
    Randomized sequence of glasdegib supra-therapeutic exposure, Placebo and moxifloxacin active control administration. This treatment will be in four separate sequences with four periods per sequence. Each period will be separated by a washout of atleast 6 days.
    Intervention: Drug: Glasdegib Supra-therapeutic Exposure
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 18, 2017)
36
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 16, 2017
Actual Primary Completion DateSeptember 23, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 1. 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 12 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.

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

    3. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.

    4. Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

    Exclusion Criteria:

    • 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 atleast one 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.

    History of known QTc prolongation or ECG abnormalities.

    Self-reported history of risk factors for QT prolongation or torsades de pointes (eg, organic heart disease, congestive heart failure, hypokalemia, hypomagnesemia,congenital long QT syndrome, myocardial ischemia or infarction, congenital deafness, and family history of sudden death, or a family history of congenital QT syndrome).

    Self-reported history of sick sinus syndrome, first, second, or third degree atrioventricular (AV) block, myocardial infarction, pulmonary congestion, cardiac arrhythmia, prolonged QT interval or conduction abnormalities, or any other clinically significant cardiovascular disease history.

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03162900
Other Study ID Numbers  ICMJE B1371023
2017-001295-38 ( EudraCT Number )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product:No
Studies a U.S. FDA-regulated Device Product:No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da....
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateSeptember 2019

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now