Renal ImpairmentPhase 1NCT03596567
Glasdegib Renal Impairment Study
A Phase 1 study testing Glasdegib single 100 mg dose in normal healthy subjects, Glasdegib single 100 mg dose in moderate renal impairment subjects and Glasdegib single 100 mg dose in severe renal impairment subjects in people with Renal Impairment, run by Pfizer at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Impairment
- What is being tested?
- Glasdegib single 100 mg dose in normal healthy subjects, Glasdegib single 100 mg dose in moderate renal impairment subjects and Glasdegib single 100 mg dose in severe renal impairment subjects
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 3 sitesUnited States
- Study dates
- 17 May 2018to 19 Sep 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- Female subjects of nonchildbearing potential must meet at least 1 of the following criteria:
- 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;
- Have undergone a documented hysterectomy and/or bilateral oophorectomy;
- Have medically confirmed ovarian failure. All other female subjects (including females with tubal ligations) are considered to be of childbearing potential.
- Body mass index (BMI) of 17.5 to 40 kg/m2; and a total body weight >50 kg (110 lb).
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- 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.
- 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 -
- Normal renal function, eGFR=>90 mL/min, based on the MDRD equation.
- 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
- 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).
- 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.
- Any form of renal impairment except acute nephritic syndrome (subjects with history of previous nephritic syndrome but in remission can be included).
- Meet one of the following eGFR criteria during the screening period based on the MDRD equation:
- Moderate renal impairment: eGFR 30 mL/min and <60 mL/min, or
- 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.
Who cannot join
- -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.
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- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Miami Division of Clinical Pharmacology
Miami, Florida, 33136
University of Miami, Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Prism Clinical Research LLC
Saint Paul, Minnesota, 55114
About this study
Official title: A PHASE 1, OPEN-LABEL, SINGLE DOSE, PARALLEL GROUP STUDY TO EVALUATE THE PHARMACOKINETICS OF GLASDEGIB (PF-04449913) IN SUBJECTS WITH IMPAIRED RENAL FUNCTION
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.
- Conditions
- Renal Impairment
- Being tested
- Glasdegib single 100 mg dose in normal healthy subjects, Glasdegib single 100 mg dose in moderate renal impairment subjects, Glasdegib single 100 mg dose in severe renal impairment subjects
- Keywords
- Glasdegib, PF-04449913, Pharmacokinetics, Renal Impairment
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glasdegib single 100 mg dose in normal healthy subjectsDrug
A single dose of 100 mg glasdegib tablet will be administered after an overnight fast, followed by serial PK collection, discharge and follow -up.
Glasdegib single 100 mg dose in moderate renal impairment subjectsDrug
A single dose of 100 mg glasdegib tablet will be administered to subjects with moderate renal impairment, after an overnight fast, followed by serial PK collection, discharge and follow -up.
Glasdegib single 100 mg dose in severe renal impairment subjectsDrug
A single dose of 100 mg glasdegib tablet will be administered to subjects with severe renal impairment, after an overnight fast, followed by serial PK collection, discharge and follow -up.
| Study group | Role | What they receive |
|---|---|---|
| Normal Renal Function Group | Experimental | Subjects with estimated glomerular filtration rate (eGFR) of => 90 ml/min Receives: Drug: Glasdegib single 100 mg dose in normal healthy subjects |
| Moderate Renal Impairment Group | Experimental | Subjects with estimated glomerular filtration rate (eGFR) of => 30ml/min and < 60 ml/min Receives: Drug: Glasdegib single 100 mg dose in moderate renal impairment subjects |
| Severe Renal Impairment Group | Experimental | Subjects with estimated glomerular filtration rate (eGFR) of < 30 ml/min and not requiring dialysis Receives: Drug: Glasdegib single 100 mg dose in severe renal impairment subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax)
Measured: 6 days
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Measured: 6 days
Secondary outcomes (44)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).
concomitant medication and adverse event monitoring.
Measured: 34 days
PR/ECGs
PR interval (msec),
Measured: 34 days
Hematology Lab Panel
Platelet count (10^3/mm^3)
Measured: 34 days
BUN /Chemistry Lab Panel
BUN (mg/dL)
Measured: 34 days
pH/Urinalysis Lab Panel
pH (no unit)
Measured: 34 days
Blood Pressure
Supine Systolic and Diastolic blood pressure (mm of Hg). Reported as Systolic/Diastolic
Measured: 34 days
Pulse Rate
Pulse Rate will be reported in beats per minute.
Measured: 34 days
ECGs
Heart Rate (beats per minute)
Measured: 34 days
Hemoglobin /Hematology Lab Panel
Hemoglobin (g/dL)
Measured: 34 days
Hematology Lab Panel
Hematocrit (%)
Measured: 34 days
Hematology Lab Panel
RBC Count (10^6/mm^3)
Measured: 34 days
Hematology Lab Panel
MCV (femto Liters)
Measured: 34 days
Hematology Lab Panel
MCH (pictograms/cell)
Measured: 34 days
Potassium/Chemistry Lab Panel
Potassium (Meq/L)
Measured: 34 days
AST/Chemistry Lab Panel
AST (U/L)
Measured: 34 days
Albumin/Chemistry Lab Panel
Albumin (g/dL)
Measured: 34 days
MCHC/Hematology Lab Panel
MCHC (10^3/mm^3)
Measured: 34 days
WBC count/Hematology Lab Panel
WBC count (10^3/mm^3),
Measured: 34 days
Total neutrophils/Hematology Lab Panel
Total neutrophils (Abs)(10^3/mm^3),
Measured: 34 days
Eosinophils/Hematology Lab Panel
Eosinophils (Abs)(10^3/mm^3
Measured: 34 days
Monocytes/Hematology Lab Panel
Monocytes (Abs)(10^3/mm^3)
Measured: 34 days
Basophils/Hematology Lab Panel
Basophils (Abs) (10^3/mm^3)
Measured: 34 days
Lymphocytes/Hematology Lab Panel
Lymphocytes (Abs) (10^3/mm^3)
Measured: 34 days
Total Protein/Chemistry Lab Panel
Total Protein (g/dL)
Measured: 34 days
ALT/Chemistry Lab Panel
ALT (U/L)
Measured: 34 days
Alkaline Phosphate/Chemistry Lab Panel
Alkaline Phosphate (U/L)
Measured: 34 days
Sodium/Chemistry Lab Panel
Sodium (Meq/L)
Measured: 34 days
Chloride/Chemistry Lab Panel
Chloride (Meq/L)
Measured: 34 days
Creatinine/Chemistry Lab Panel
Creatinine (mg/dL),
Measured: 34 days
Glucose/Chemistry Lab Panel
Glucose (mg/dL),
Measured: 34 days
Calcium/Chemistry Lab Panel
Calcium (mg/dL),
Measured: 34 days
Total Bilirubin/Chemistry Lab Panel
Total Bilirubin (mg/dL),
Measured: 34 days
Uric acid/Chemistry Lab Panel
Uric acid (mg/dL)
Measured: 34 days
Magnesium/Chemistry Lab Panel
Magnesium (mg/dL)
Measured: 34 days
QTc/ECGs
QTc interval (msec)
Measured: 34 days
QRS/ECGs
QRS interval (msec)
Measured: 34 days
Glucose/Urinalysis Lab Panel
Glucose (qual) (no unit)
Measured: 34 days
Protein/Urinalysis Lab Panel
Protein (qual) (no unit)
Measured: 34 days
Blood/Urinalysis Lab Panel
Blood (qual) (no units)
Measured: 34 days
Ketones/Urinalysis Lab Panel
Ketones (no units)
Measured: 34 days
Nitrites/Urinalysis Lab Panel
Nitrites (no units)
Measured: 34 days
Leukocyte /Urinalysis Lab Panel
Leukocyte esterase (no units)
Measured: 34 days
Urobilinogen/Urinalysis Lab Panel
Urobilinogen (no unit)
Measured: 34 days
Urine bilirubin/Urinalysis Lab Panel
Urine bilirubin (no unit)
Measured: 34 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2018
- Study start17 May 2018
- Primary completion28 Aug 2018
- Study completion19 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal ImpairmentStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03596567
- Sponsor's protocol ID
- B1371017
- Status last verified
- Aug 2019
- First submitted
- 2 Apr 2018
- Last updated
- 29 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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/data\_requests.
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 Feb;87(2):241-250. doi: 10.1007/s00280-020-04207-9. Epub 2021 Jan 3.
PubMed 33388951
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PHASE 1, OPEN-LABEL, SINGLE DOSE, PARALLEL GROUP STUDY TO EVALUATE THE PHARMACOKINETICS OF GLASDEGIB (PF-04449913) IN SUBJECTS WITH IMPAIRED RENAL FUNCTION
- ClinicalTrials.gov ID
- NCT03596567
- Acronym / sponsor ID
- B1371017
- Conditions
- Renal Impairment
- Keywords
- Glasdegib, PF-04449913, Pharmacokinetics, Renal Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 17 May 2018 (actual)
- Primary completion
- 28 Aug 2018 (actual)
- Study completion
- 19 Sep 2018 (actual)
- First posted
- 24 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal Renal Function Group | Experimental | Drug: Glasdegib single 100 mg dose in normal healthy subjectsSubjects with estimated glomerular filtration rate (eGFR) of => 90 ml/min |
| Moderate Renal Impairment Group | Experimental | Drug: Glasdegib single 100 mg dose in moderate renal impairment subjectsSubjects with estimated glomerular filtration rate (eGFR) of => 30ml/min and < 60 ml/min |
| Severe Renal Impairment Group | Experimental | Drug: Glasdegib single 100 mg dose in severe renal impairment subjectsSubjects with estimated glomerular filtration rate (eGFR) of < 30 ml/min and not requiring dialysis |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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.
- Female subjects of nonchildbearing potential must meet at least 1 of the following criteria:
- Body mass index (BMI) of 17.5 to 40 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 (or a legal representative) 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.
Key exclusion criteria (13 listed)
- -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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glasdegib single 100 mg dose in normal healthy subjectsA single dose of 100 mg glasdegib tablet will be administered after an overnight fast, followed by serial PK collection, discharge and follow -up. | Drug | Normal Renal Function Group |
| Glasdegib single 100 mg dose in moderate renal impairment subjectsA single dose of 100 mg glasdegib tablet will be administered to subjects with moderate renal impairment, after an overnight fast, followed by serial PK collection, discharge and follow -up. | Drug | Moderate Renal Impairment Group |
| Glasdegib single 100 mg dose in severe renal impairment subjectsA single dose of 100 mg glasdegib tablet will be administered to subjects with severe renal impairment, after an overnight fast, followed by serial PK collection, discharge and follow -up. | Drug | Severe Renal Impairment Group |
Primary outcome
Maximum Observed Plasma Concentration (Cmax)
Time frame: 6 days
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
Time frame: 6 days
AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
44 secondary outcomes
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).
Time frame: 34 days
PR/ECGs
Time frame: 34 days
Hematology Lab Panel
Time frame: 34 days
BUN /Chemistry Lab Panel
Time frame: 34 days
pH/Urinalysis Lab Panel
Time frame: 34 days
Blood Pressure
Time frame: 34 days
Pulse Rate
Time frame: 34 days
ECGs
Time frame: 34 days
Hemoglobin /Hematology Lab Panel
Time frame: 34 days
Hematology Lab Panel
Time frame: 34 days
Hematology Lab Panel
Time frame: 34 days
Hematology Lab Panel
Time frame: 34 days
Hematology Lab Panel
Time frame: 34 days
Potassium/Chemistry Lab Panel
Time frame: 34 days
AST/Chemistry Lab Panel
Time frame: 34 days
Albumin/Chemistry Lab Panel
Time frame: 34 days
MCHC/Hematology Lab Panel
Time frame: 34 days
WBC count/Hematology Lab Panel
Time frame: 34 days
Total neutrophils/Hematology Lab Panel
Time frame: 34 days
Eosinophils/Hematology Lab Panel
Time frame: 34 days
Monocytes/Hematology Lab Panel
Time frame: 34 days
Basophils/Hematology Lab Panel
Time frame: 34 days
Lymphocytes/Hematology Lab Panel
Time frame: 34 days
Total Protein/Chemistry Lab Panel
Time frame: 34 days
ALT/Chemistry Lab Panel
Time frame: 34 days
Alkaline Phosphate/Chemistry Lab Panel
Time frame: 34 days
Sodium/Chemistry Lab Panel
Time frame: 34 days
Chloride/Chemistry Lab Panel
Time frame: 34 days
Creatinine/Chemistry Lab Panel
Time frame: 34 days
Glucose/Chemistry Lab Panel
Time frame: 34 days
Calcium/Chemistry Lab Panel
Time frame: 34 days
Total Bilirubin/Chemistry Lab Panel
Time frame: 34 days
Uric acid/Chemistry Lab Panel
Time frame: 34 days
Magnesium/Chemistry Lab Panel
Time frame: 34 days
QTc/ECGs
Time frame: 34 days
QRS/ECGs
Time frame: 34 days
Glucose/Urinalysis Lab Panel
Time frame: 34 days
Protein/Urinalysis Lab Panel
Time frame: 34 days
Blood/Urinalysis Lab Panel
Time frame: 34 days
Ketones/Urinalysis Lab Panel
Time frame: 34 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2019.
- Derived from this study: PubMed 33388951Shaik 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 Feb;87(2):241-250. doi: 10.1007/s00280-020-04207-9. Epub 2021 Jan 3.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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/data_requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Glasdegib single 100 mg dose in normal healthy subjects, Glasdegib single 100 mg dose in moderate renal impairment subjects and Glasdegib single 100 mg dose in severe renal impairment subjects in people with Renal Impairment, run by Pfizer at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Observed Plasma Concentration (Cmax) (time frame: 6 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03596567, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2019.