ABOUT THIS STUDY
FOR MORE INFORMATION
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1. Healthy female subjects of non child bearing potential and/or male subjects who, at the time of screening, are between the ages of 18 and 75 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.
2. 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) are considered to be of childbearing potential.
3. Body mass index (BMI) of 17.5 to 40 kg/m2; and a total body weight >50 kg (110 lb).
4. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
5. Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
Subjects with Normal Renal Function will Need to Meet the Following Criteria in addition -
1. Normal renal function, eGFR=>90 mL/min, based on the MDRD equation.
2. Matched for age (+/-10years) weight +/-15kg, and gender to subjects in the impaired renal function groups
Subjects with Impaired Renal Function will Need to Meet the Following Criteria in Addition to Those Above
1. Good general health commensurate with the population with chronic kidney disease (renal impairment). 'Health' is defined as no clinically relevant abnormalities (with the exception of hypertension, diabetes mellitus, hyperparathyroidism, ischemic heart disease, etc. as long as, in the opinion of the investigator, the subject is medically stable, is on a stable drug regimen and can abide by the meals and dietary restrictions outlined in protocol identified by a detailed medical history, full physical examination, measurement of pulse rate and 12 lead ECG as well as clinical laboratory tests (except serum creatinine and eGFR).
2. Stable drug regimen defined as not starting a new drug or changing dosage within seven days or five half lives (whichever is longer) before dosing the study drug.
3. Any form of renal impairment except acute nephritic syndrome (subjects with history of previous nephritic syndrome but in remission can be included).
4. Meet one of the following eGFR criteria during the screening period based on the MDRD equation:
1. Moderate renal impairment: eGFR 30 mL/min and <60 mL/min, or
2. Severe renal impairment: eGFR <30 mL/min, but not requiring hemodialysis. For subjects in all groups, the values of serum creatinine obtained at the two screening visits should not be more than 20% different.
-Any condition possibly affecting drug absorption (eg, gastrectomy,
achlorhydria).
Renal allograft recipients
Urinary incontinence without catheterization.
Concurrent use of any of the following food or drugs known to inhibit CYP3A4
(consult the Sponsor if in doubt whether a food or a drug falls into any of the
above categories) within 7 days or 5 half lives (whichever is longer) prior to
the dose of glasdegib, until the completion of the last PK sample collection.
Concurrent use of any of the following food or drugs known to induce CYP3A4
(consult the Sponsor if in doubt whether a food or a drug falls into any of the
above categories) within 12 days or 5 half lives (whichever is longer) prior to
the first dose of trial medication until the completion of the last PK sample
collection.
Pregnant female subjects; breastfeeding female subjects; fertile 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.
Subjects with ANY of the following abnormalities in clinical laboratory tests at
Screening, as assessed by the study specific laboratory and confirmed by a single
repeat test, if deemed necessary:
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level >
upper limit of normal (ULN);
- Total bilirubin level 1.5 × ULN; subjects with a history of Gilbert's
syndrome may have direct bilirubin measured and would be eligible for this
study provided the direct bilirubin level is not greater than 0.5 mg/dL.
For subjects with renal impairment, the following important additional criteria
are:
Subjects with other clinically significant disease that may affect the safety of
the subject or that may affect the pharmacokinetics of glasdegib (including drug
allergies, but excluding untreated, asymptomatic, seasonal allergies at time of
dosing). Subjects with any significant hepatic, cardiac, or pulmonary disease or
subjects who are clinically nephrotic. Hypertension, diabetes mellitus,
hyperparathyroidism, ischemic heart disease, etc is not cause for exclusion as
long as the subject is medically stable and any drugs that are administered for
these conditions are not expected to interfere with the pharmacokinetics of
glasdegib.
Screening blood pressure =>180mm Hg (systolic) or>=110 mm Hg (diastolic),
following at least 5 minutes of supine rest. If initial blood pressure (BP) is
180 mm Hg (systolic) or 110 mm Hg (diastolic), the BP should be repeated two more
times and the average of the three BP values should be used to determine the
subject's eligibility.
Screening supine 12 lead ECG demonstrating QTcF >470 msec or a QRS interval >120
msec. If initial QTcF exceeds 470 msec, or QRS exceeds 120 msec, the ECG should
be repeated two more times and the average of the three QTcF or QRS values should
be used to determine the subject's eligibility.
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Descriptive Information | |||||
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Brief Title ICMJE | Glasdegib Renal Impairment Study | ||||
Official Title ICMJE | A PHASE 1, OPEN-LABEL, SINGLE DOSE, PARALLEL GROUP STUDY TO EVALUATE THE PHARMACOKINETICS OF GLASDEGIB (PF-04449913) IN SUBJECTS WITH IMPAIRED RENAL FUNCTION | ||||
Brief 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. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Basic Science | ||||
Condition ICMJE | Renal Impairment | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Shaik N, LaBadie RR, Hee B, Chan G. Evaluation of the impact of renal impairment on the pharmacokinetics of glasdegib in otherwise healthy volunteers. Cancer Chemother Pharmacol. 2021 Jan 3. doi: 10.1007/s00280-020-04207-9. [Epub ahead of print] | ||||
* 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 | 18 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | September 19, 2018 | ||||
Actual Primary Completion Date | August 28, 2018 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Subjects with Normal Renal Function will Need to Meet the Following Criteria in addition -
Subjects with Impaired Renal Function will Need to Meet the Following Criteria in Addition to Those Above
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older 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 | NCT03596567 | ||||
Other Study ID Numbers ICMJE | B1371017 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||
Study Sponsor ICMJE | Pfizer | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||
Verification Date | August 2019 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |