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Trial record 36 of 3119 for:    Area Under Curve AND Healthy

A Study Of Glasdegib In Healthy Volunteers To Establish The Bioequivalence Of The Phase 2 Formulation To The ICH Formulation (B1371026)

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ClinicalTrials.gov Identifier: NCT03130556
Recruitment Status : Completed
First Posted : April 26, 2017
Last Update Posted : August 1, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE April 21, 2017
First Posted Date  ICMJE April 26, 2017
Last Update Posted Date August 1, 2017
Actual Study Start Date  ICMJE May 1, 2017
Actual Primary Completion Date July 6, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 21, 2017)
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 5 days ]
  • Area Under the Curve From Time Zero to Last Measured Time Point [AUC (0 - t)] [ Time Frame: 5 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03130556 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 21, 2017)
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] [ Time Frame: 5 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Of Glasdegib In Healthy Volunteers To Establish The Bioequivalence Of The Phase 2 Formulation To The ICH Formulation
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Glasdegib BE and Food
    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 receive a 100 mg single dose ICH tablet after a high fat, high calorie meal.
    Interventions:
    • Drug: Glasdegib
    • Other: High Fat, High Calorie Meal
  • Experimental: Glasdegib BE and PPI Effect
    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 receive a 100 mg single dose ICH tablet in the fasted state after repeated daily dosing with rabeprazole.
    Interventions:
    • Drug: Glasdegib
    • Drug: Rabeprazole
Publications * Shaik N, Hee B, Wei H, LaBadie RR. Evaluation of the effects of formulation, food, or a proton-pump inhibitor on the pharmacokinetics of glasdegib (PF-04449913) in healthy volunteers: a randomized phase I study. Cancer Chemother Pharmacol. 2019 Mar;83(3):463-472. doi: 10.1007/s00280-018-3748-8. Epub 2018 Dec 10.

*   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: April 21, 2017)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 21, 2017
Actual Primary Completion Date July 6, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03130556
Other Study ID Numbers  ICMJE B1371026
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP