CMLPhase 1NCT03747679
Palatability (Taste) of Oral Formulations of Bosutinib
A Phase 1 study testing 200 Mg capsules of bosutinib in Water solution, bosunitib sorbitol and Bosutinib Mannitol in people with CML, run by Pfizer at 1 site in Belgium.
Trial summary
Healthy Adult Volunteer Taste Study of Oral Formulations of Bosutinib for Pediatric Use. This will be a single-blind, randomized, multiple-period (dosing over 4 days) study in healthy male and/or female participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- CML
- What is being tested?
- 200 Mg capsules of bosutinib in Water solution, bosunitib sorbitol and Bosutinib Mannitol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteBelgium
- Study dates
- 22 Nov 2018to 14 Jan 2019
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age and Sex:
- Female participants of non-childbearing potential and/or male participants able to father children must be 18 to 55 years of age, inclusive, at the time of signing the informed consent document (ICD).
- -Refer to Appendix 4 for reproductive criteria for male (Section 10.4.1) and female (Section 10.4.2) participants.
- Type of Participant and Disease Characteristics:
- Male and female participants who are overtly healthy as determined by medical evaluation including a detailed medical history, limited physical examination, including blood pressure (BP) and pulse rate measurement, or clinical laboratory tests.
- Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
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- Weight:
- Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >45 kg (99 lbs).
- Informed Consent:
- Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the informed consent document (ICD) and in this protocol.
Who cannot join
- Medical Conditions:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- A history of hypersensitivity to the active compounds or to any inactive ingredients (excipients) contained in the formulations.
- Participants with conditions that affect their ability to taste - ie, dysgeusia, respiratory infection, cold, etc.
- History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or hepatitis C antibody (HCVAb). As an exception, a positive hepatitis B surface antibody (HBsAb) as a result of participant vaccination is permissible.
- Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
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- Prior/Concomitant Therapy:
- Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of investigational product. (Refer to Section 6.5 for additional details).
- Prior/Concurrent Clinical Study Experience:
- Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of investigational product used in this study (whichever is longer).
- Diagnostic Assessments:
- A positive urine drug test.
- Use of tobacco-containing products.
- Screening supine blood pressure (BP) 140 mm Hg (systolic) or 90 mm Hg (diastolic), following at least 5 minutes of supine rest. If BP is 140 mm Hg (systolic) or 90 mm Hg (diastolic), the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the participant's eligibility.
- Baseline 12 lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, baseline corrected QT (QTc) interval >450 msec, complete left bundle branch block [LBBB], signs of an acute or indeterminate age myocardial infarction, ST T interval changes suggestive of myocardial ischemia, second or third degree atrioventricular [AV] block, or serious bradyarrhythmias or tachyarrhythmias). If the baseline uncorrected QT interval is >450 msec, this interval should be rate corrected using the Fridericia method and the resulting QTcF should be used for decision making and reporting. 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 participant's eligibility. Computer interpreted ECGs should be overread by a physician experienced in reading ECGs before excluding participants.
- Participants 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 1.5 × upper limit of normal (ULN);
- Total bilirubin level 1.5 × ULN; participants 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 ULN.
- Other Exclusions:
- History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening. Binge drinking is defined as a pattern of consuming 5 (male) and 4 (female) or more alcoholic drinks in about 2 hours. As a general rule, alcohol intake should not exceed 14 units per week (1 unit = 8 ounces (240 mL) beer, 1 ounce (30 mL) of 40% spirit or 3 ounces (90 mL) of wine).
- Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
- Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of this protocol.
- Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or Pfizer employees, including their family members, directly involved in the conduct of the study.
- Male participants with partners currently pregnant; male participants able to father children who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product or longer based upon the compound's half-life characteristics.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A SINGLE-BLIND, RANDOMIZED, MULTIPLE-PERIOD STUDY IN HEALTHY ADULT VOLUNTEERS TO INVESTIGATE THE PALATABILITY OF PROTOTYPE AGE APPROPRIATE ORAL FORMULATIONS OF BOSUTINIB FOR PEDIATRIC USE
Healthy Adult Volunteer Taste Study of Oral Formulations of Bosutinib for Pediatric Use. This will be a single-blind, randomized, multiple-period (dosing over 4 days) study in healthy male and/or female participants. Approximately 8 participants will assess the sensory attributes of different powder for oral suspension (POS) formulations.
Read the detailed description
Taste evaluations for the formulations (Formulations A to N) in Sessions 1 to 4 each contains 4 periods. All the planned formulations in this study will have a bosutinib amount equal to 200 mg in each taste assessment. Session 1 consists of bosutinib POS, sorbitol base in water (A); bosutinib POS, mannitol base in water (B); and bosutinib capsules to be opened into water (C). Session 2 consists of bosutinib POS, mannitol base in low % (D) and in high % (E) sodium saccharine sweetener vehicles, respectively; bosutinib POS, mannitol base in low % (F) and high % (G) strawberry flavour vehicles, respectively. Session 3 consists of bosutinib capsules to be opened into low % (H) and high % (I) sodium saccharine sweetener vehicles, respectively; bosutinib capsules to be opened into low % (J) and high % (K) strawberry flavour vehicles, respectively. Session 4 consists of bosutinib capsules opened onto apple sauce (L); bosutinib capsules opened onto full fat natural yoghurt (M); and bosutinib capsules to be opened into water (N). Participants will be assigned to one of the treatment sequences available for each session. Except at session 4 for treatments L and M, each formulation will be presented to the participants in a blinded fashion.
Participants will be required to not swallow, rather to only swish the bosutinib containing liquid in their mouths for approximately 10 seconds, after which the liquid will be spat out. Each participant will record the sensory attributes at timed intervals of 0 (immediately after dosing), 5, 10 and 20 minutes after spitting using a Bosutinib Taste Assessment Questionnaire.
- Conditions
- CML
- Being tested
- 200 Mg capsules of bosutinib in Water solution, bosunitib sorbitol, Bosutinib Mannitol, bosutinib in mannitol low sweet, bosutinib in mannitol high sweet
- Keywords
- CML; palatability; taste; pediatric formulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
200 Mg capsules of bosutinib in Water solutionDrug
200 mg (4X50) Capsules in water
bosunitib sorbitolDrug
200 Mg of bosutinib sorbitol solution
Bosutinib MannitolDrug
Bosutinib mannitol solution
bosutinib in mannitol low sweetDrug
bosutinib in mannitol solution low sweet
bosutinib in mannitol high sweetDrug
bosutinib in mannitol high sweet
bosutinib taste low flavourDrug
bosutinib solution low flavour
bosutinib high flavourDrug
bosutinib solution high flavour
bosutinib capsules in applesauceDrug
Bosutinib capsules in applesauce
Bosutinib capsules in yogurtDrug
bosutinib capsules in yogurt
bosutinib capsules in waterDrug
sham comparator, bosutinb in water retest
Bosutinib capsules in low sweetDrug
bosutinib capsules in low sweet
bosutinib capsules high sweetDrug
Bosutinib capsules high sweet
bosutinib capsules low flavourDrug
Bosutinib capsules low flavour
bosutinib capsules high flavourDrug
bosutinib capsules in high flavour
| Study group | Role | What they receive |
|---|---|---|
| A- Bosutinib in water | Experimental | 200 Mg of bosutinib (50 mg capsule x4) in Water solution Receives: Drug: 200 Mg capsules of bosutinib in Water solution |
| B- bosutinib in sorbitol | Experimental | 200 Mg of bosutinib sorbitol base in water solution Receives: Drug: bosunitib sorbitol |
| C- - bosutinib mannitol | Experimental | 200 Mg of bosutinib powder mannitol base in water solution Receives: Drug: Bosutinib Mannitol |
| D - bosutinib in mannitol low sweet | Experimental | 200 Mg of bosutinib mannitol low sweet solution Receives: Drug: bosutinib in mannitol low sweet |
| E- - bosutinib in mannitol high sweet | Experimental | 200 Mg of bosutinib High % sweet mannitol solution Receives: Drug: bosutinib in mannitol high sweet |
| F- - bosutinib low flavour | Experimental | Taste assessment of 200 Mg of bosutinib low % Flavour Receives: Drug: bosutinib taste low flavour |
| G- bosutinib high flavour | Experimental | Taste assessment of 200 Mg of bosutinib high percentage of flavor in water Receives: Drug: bosutinib high flavour |
| H- - bosutinib capsules in low sweet | Experimental | Taste assessment of 200 Mg of bosutinib (50 mg x4 capsules) low % sweet Receives: Drug: Bosutinib capsules in low sweet |
| I - bosutinib capsules high sweet | Experimental | 200 Mg of bosutinib (4 X 50 mg capsules)in high % sweetener Receives: Drug: bosutinib capsules high sweet |
| J- - bosutinib capsules low flavour | Experimental | Taste assessment of 200 Mg of bosutinib (50 mg X4 capsules) in Low % flavour Water solution Receives: Drug: bosutinib capsules low flavour |
| K - bosutinib capsules high flavour | Experimental | Taste assessment of 200 Mg of bosutinib (50 mg X 4 capsules) in high % flavour Receives: Drug: bosutinib capsules high flavour |
| L - bosutinib capsules applesauce | Experimental | 200 Mg of bosutinib (50 mg x 4 capsules) in applesauce Receives: Drug: bosutinib capsules in applesauce |
| M - bosutinib capsules full fat yougurt | Experimental | 200 Mg of bosutinib (50 mg x 4 capsules) in full fat yogurt Receives: Drug: Bosutinib capsules in yogurt |
| N - bosutinib capsules in water (retest) | Experimental | 200 Mg of bosutinib (50 mg x 4 capsules) in Water (retest) Receives: Drug: bosutinib capsules in water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Taste evaluation using Bosutinib Taste Assessment Questionnaire toward formulation for pediatric use (Bosutinib in Water)
This study will enable the selection of the commercial formulation for pediatric use of bosutinib
Measured: baseline to one month
Taste evaluation using Bosutinib Taste Assessment Questionnaire toward formulation for pediatric use (Bosutinib sorbitol)
This study will enable the selection of the commercial formulation for pediatric use of bosutinib
Measured: baseline to one month
Taste evaluation using Bosutinib Taste Assessment Questionnaire toward formulation for pediatric use (Bosutinib mannitol)
This study will enable the selection of the commercial formulation for pediatric use of bosutinib
Measured: baseline to one month
Taste evaluation using Bosutinib Taste Assessment Questionnaire toward formulation for pediatric use (Bosutinib mannitol low sweet)
This study will enable the selection of the commercial formulation for pediatric use of bosutinib
Measured: baseline to one month
Taste evaluation using Bosutinib Taste Assessment Questionnaire toward formulation for pediatric use(Bosutinib mannitol high sweet)
This study will enable the selection of the commercial formulation for pediatric use of bosutinib
Measured: baseline to one month
Taste evaluation using Bosutinib Taste Assessment Questionnaire toward formulation for pediatric use (Bosutinib mannitol in low flavour strawberry)
This study will enable the selection of the commercial formulation for pediatric use of bosutinib
Measured: baseline to one month
Taste evaluation using Bosutinib Taste Assessment Questionnaire toward formulation for pediatric use (Bosutinib mannitol high flavour strawberry)
This study will enable the selection of the commercial formulation for pediatric use of bosutinib
Measured: baseline to one month
Taste evaluation using Bosutinib Taste Assessment Questionnaire toward formulation for pediatric use (Bosutinib 50 mg capsules X4) low sweet
This study will enable the selection of the commercial formulation for pediatric use of bosutinib
Measured: baseline to one month
Taste evaluation using Bosutinib Taste Assessment Questionnaire toward formulation for pediatric use (Bosutinib 50 mg capsules X4) high sweet
This study will enable the selection of the commercial formulation for pediatric use of bosutinib
Measured: baseline to one month
Taste evaluation using Bosutinib Taste Assessment Questionnaire toward formulation for pediatric use (Bosutinib 50 mg capsules X4) low flavour
This study will enable the selection of the commercial formulation for pediatric use of bosutinib
Measured: baseline to one month
Taste evaluation using Bosutinib Taste Assessment Questionnaire toward formulation for pediatric use (Bosutinib 50 mg capsules X4) high flavour
This study will enable the selection of the commercial formulation for pediatric use of bosutinib
Measured: baseline to one month
Taste evaluation using Bosutinib Taste Assessment Questionnaire toward formulation for pediatric use (Bosutinib 50 mg capsules X4) applesauce
This study will enable the selection of the commercial formulation for pediatric use of bosutinib
Measured: baseline to one month
Taste evaluation using Bosutinib Taste Assessment Questionnaire toward formulation for pediatric use (bosutinib 4 capsules 50 mg bosutinib in yogurt
This study will enable the selection of the commercial formulation for pediatric use of bosutinib
Measured: baseline to one month
Taste evaluation using Bosutinib Taste Assessment Questionnaire toward formulation for pediatric use (Bosutinib 50 mg capsules X4 in water retest)
This study will enable the selection of the commercial formulation for pediatric use of bosutinib
Measured: baseline to one month
Secondary outcomes (14)
Number or treatment emergent treatment related adverse events following oral administration of bosutinib solution bosutinib 200 mg sorbitol
Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to Bosutinib was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Measured: Baseline to one month
Number or treatment emergent treatment related adverse events following oral administration of 200 mg bosutinib powder mannitol solution
Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to Bosutinib was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Measured: baseline to one month
Number of patients with treatment emergent treatment related adverse events bosutinib 50 mg x4 capsules in water
Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to Bosutinib was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Measured: baseline to one month
Number of patients with treatment emergent treatment related adverse events bosutinib 200 mg mannitol low sweet
Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to Bosutinib was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Measured: baseline to one month
number of patients with treatment emergent or treatment related adverse events bosutinib 200 mg mannitol high sweet
Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to Bosutinib was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Measured: baseline to one month
number of patients with treatment emergent treatment related adverse events bosutinib 200 mg mannitol high flavour (strawberry)
Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to Bosutinib was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Measured: baseline to one month
Number or treatment emergent treatment related adverse events following oral administration of bosutinib 200 mg solution mannitol low flavour
Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to Bosutinib was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Measured: baseline to one month
Number or treatment emergent treatment related adverse events following oral administration of bosutinib solution 50 mg x 4 capsules high sweet
Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to Bosutinib was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Measured: baseline to one month
Number or treatment emergent treatment related adverse events following oral administration of bosutinib solution capsules 4 x 50mg low flavour
Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to Bosutinib was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Measured: baseline to one month
Number or treatment emergent treatment related adverse events following oral administration of bosutinib solution capsules 50 mg X4 high flavour
Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to Bosutinib was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Measured: baseline to one month
Number or treatment emergent treatment related adverse events following oral administration of bosutinib solution capsules 4 x 50 mg applesauce
Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to Bosutinib was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Measured: baseline to one month
Number or treatment emergent treatment related adverse events following oral administration of bosutinib solution capsules 50 mg x4 in yogurt
Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to Bosutinib was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Measured: baseline to one month
Number of treatment emergent treatment related adverse events following oral administration of 4 X50 mg capsules bosutinib low sweet solution
Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to Bosutinib was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Measured: baseline to one month
Number of treatment emergent treatment related adverse events following oral administration of bosutinib 50 mg capsules x4 in water (retest)
Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to Bosutinib was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Measured: baseline to one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start22 Nov 2018
- Primary completion14 Jan 2019
- Study completion14 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CMLStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- This will be a single-blind, randomized, multiple-period (dosing over 4 days) study in healthy male and/or female participants. Approximately 8 participants will assess the sensory attributes of each of the formulation options using Bosutinib Taste Assessment Questionnaire
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 8 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
- NCT03747679
- Sponsor's protocol ID
- B1871057
- Other IDs
- 2018-002346-37, BCHILD TASTE, 2018
- Status last verified
- Jul 2020
- First submitted
- 14 Nov 2018
- Last updated
- 10 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A SINGLE-BLIND, RANDOMIZED, MULTIPLE-PERIOD STUDY IN HEALTHY ADULT VOLUNTEERS TO INVESTIGATE THE PALATABILITY OF PROTOTYPE AGE APPROPRIATE ORAL FORMULATIONS OF BOSUTINIB FOR PEDIATRIC USE
- ClinicalTrials.gov ID
- NCT03747679
- Acronym / sponsor ID
- B1871057
- Conditions
- CML
- Keywords
- CML; palatability; taste; pediatric formulation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 22 Nov 2018 (actual)
- Primary completion
- 14 Jan 2019 (actual)
- Study completion
- 14 Jan 2019 (actual)
- First posted
- 20 Nov 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.
Healthy Adult Volunteer Taste Study of Oral Formulations of Bosutinib for Pediatric Use. This will be a single-blind, randomized, multiple-period (dosing over 4 days) study in healthy male and/or female participants. Approximately 8 participants will assess the sensory attributes of different powder for oral suspension (POS) formulations.
Detailed description
Taste evaluations for the formulations (Formulations A to N) in Sessions 1 to 4 each contains 4 periods. All the planned formulations in this study will have a bosutinib amount equal to 200 mg in each taste assessment. Session 1 consists of bosutinib POS, sorbitol base in water (A); bosutinib POS, mannitol base in water (B); and bosutinib capsules to be opened into water (C). Session 2 consists of bosutinib POS, mannitol base in low % (D) and in high % (E) sodium saccharine sweetener vehicles, respectively; bosutinib POS, mannitol base in low % (F) and high % (G) strawberry flavour vehicles, respectively. Session 3 consists of bosutinib capsules to be opened into low % (H) and high % (I) sodium saccharine sweetener vehicles, respectively; bosutinib capsules to be opened into low % (J) and high % (K) strawberry flavour vehicles, respectively. Session 4 consists of bosutinib capsules opened onto apple sauce (L); bosutinib capsules opened onto full fat natural yoghurt (M); and bosutinib capsules to be opened into water (N). Participants will be assigned to one of the treatment sequences available for each session. Except at session 4 for treatments L and M, each formulation will be presented to the participants in a blinded fashion.
Participants will be required to not swallow, rather to only swish the bosutinib containing liquid in their mouths for approximately 10 seconds, after which the liquid will be spat out. Each participant will record the sensory attributes at timed intervals of 0 (immediately after dosing), 5, 10 and 20 minutes after spitting using a Bosutinib Taste Assessment Questionnaire.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 14
- Model description
- This will be a single-blind, randomized, multiple-period (dosing over 4 days) study in healthy male and/or female participants. Approximately 8 participants will assess the sensory attributes of each of the formulation options using Bosutinib Taste Assessment Questionnaire
| Arm | Type | Receives |
|---|---|---|
| A- Bosutinib in water | Experimental | Drug: 200 Mg capsules of bosutinib in Water solution200 Mg of bosutinib (50 mg capsule x4) in Water solution |
| B- bosutinib in sorbitol | Experimental | Drug: bosunitib sorbitol200 Mg of bosutinib sorbitol base in water solution |
| C- - bosutinib mannitol | Experimental | Drug: Bosutinib Mannitol200 Mg of bosutinib powder mannitol base in water solution |
| D - bosutinib in mannitol low sweet | Experimental | Drug: bosutinib in mannitol low sweet200 Mg of bosutinib mannitol low sweet solution |
| E- - bosutinib in mannitol high sweet | Experimental | Drug: bosutinib in mannitol high sweet200 Mg of bosutinib High % sweet mannitol solution |
| F- - bosutinib low flavour | Experimental | Drug: bosutinib taste low flavourTaste assessment of 200 Mg of bosutinib low % Flavour |
| G- bosutinib high flavour | Experimental | Drug: bosutinib high flavourTaste assessment of 200 Mg of bosutinib high percentage of flavor in water |
| H- - bosutinib capsules in low sweet | Experimental | Drug: Bosutinib capsules in low sweetTaste assessment of 200 Mg of bosutinib (50 mg x4 capsules) low % sweet |
| I - bosutinib capsules high sweet | Experimental | Drug: bosutinib capsules high sweet200 Mg of bosutinib (4 X 50 mg capsules)in high % sweetener |
| J- - bosutinib capsules low flavour | Experimental | Drug: bosutinib capsules low flavourTaste assessment of 200 Mg of bosutinib (50 mg X4 capsules) in Low % flavour Water solution |
| K - bosutinib capsules high flavour | Experimental | Drug: bosutinib capsules high flavourTaste assessment of 200 Mg of bosutinib (50 mg X 4 capsules) in high % flavour |
| L - bosutinib capsules applesauce | Experimental | Drug: bosutinib capsules in applesauce200 Mg of bosutinib (50 mg x 4 capsules) in applesauce |
| M - bosutinib capsules full fat yougurt | Experimental | Drug: Bosutinib capsules in yogurt200 Mg of bosutinib (50 mg x 4 capsules) in full fat yogurt |
| N - bosutinib capsules in water (retest) | Experimental | Drug: bosutinib capsules in water200 Mg of bosutinib (50 mg x 4 capsules) in Water (retest) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Female participants of non-childbearing potential and/or male participants able to father children must be 18 to 55 years of age, inclusive, at the time of signing the informed consent document (ICD).
- -Refer to Appendix 4 for reproductive criteria for male (Section 10.4.1) and female (Section 10.4.2) participants.
- Male and female participants who are overtly healthy as determined by medical evaluation including a detailed medical history, limited physical examination, including blood pressure (BP) and pulse rate measurement, or clinical laboratory tests.
- Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
- Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >45 kg (99 lbs).
Key exclusion criteria (24 listed)
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- A history of hypersensitivity to the active compounds or to any inactive ingredients (excipients) contained in the formulations.
- Participants with conditions that affect their ability to taste - ie, dysgeusia, respiratory infection, cold, etc.
- History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or hepatitis C antibody (HCVAb). As an exception, a positive hepatitis B surface antibody (HBsAb) as a result of participant vaccination is permissible.
- Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
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 |
|---|---|---|
| 200 Mg capsules of bosutinib in Water solution200 mg (4X50) Capsules in water | Drug | A- Bosutinib in water |
| bosunitib sorbitol200 Mg of bosutinib sorbitol solution | Drug | B- bosutinib in sorbitol |
| Bosutinib MannitolBosutinib mannitol solution | Drug | C- - bosutinib mannitol |
| bosutinib in mannitol low sweetbosutinib in mannitol solution low sweet | Drug | D - bosutinib in mannitol low sweet |
| bosutinib in mannitol high sweetbosutinib in mannitol high sweet | Drug | E- - bosutinib in mannitol high sweet |
| bosutinib taste low flavourbosutinib solution low flavour | Drug | F- - bosutinib low flavour |
| bosutinib high flavourbosutinib solution high flavour | Drug | G- bosutinib high flavour |
| bosutinib capsules in applesauceBosutinib capsules in applesauce | Drug | L - bosutinib capsules applesauce |
| Bosutinib capsules in yogurtbosutinib capsules in yogurt | Drug | M - bosutinib capsules full fat yougurt |
| bosutinib capsules in watersham comparator, bosutinb in water retest | Drug | N - bosutinib capsules in water (retest) |
| Bosutinib capsules in low sweetbosutinib capsules in low sweet | Drug | H- - bosutinib capsules in low sweet |
| bosutinib capsules high sweetBosutinib capsules high sweet | Drug | I - bosutinib capsules high sweet |
| bosutinib capsules low flavourBosutinib capsules low flavour | Drug | J- - bosutinib capsules low flavour |
| bosutinib capsules high flavourbosutinib capsules in high flavour | Drug | K - bosutinib capsules high flavour |
Primary outcome
Taste evaluation using Bosutinib Taste Assessment Questionnaire toward formulation for pediatric use (Bosutinib in Water)
Time frame: baseline to one month
This study will enable the selection of the commercial formulation for pediatric use of bosutinib
Taste evaluation using Bosutinib Taste Assessment Questionnaire toward formulation for pediatric use (Bosutinib sorbitol)
Time frame: baseline to one month
This study will enable the selection of the commercial formulation for pediatric use of bosutinib
Taste evaluation using Bosutinib Taste Assessment Questionnaire toward formulation for pediatric use (Bosutinib mannitol)
Time frame: baseline to one month
This study will enable the selection of the commercial formulation for pediatric use of bosutinib
Taste evaluation using Bosutinib Taste Assessment Questionnaire toward formulation for pediatric use (Bosutinib mannitol low sweet)
Time frame: baseline to one month
This study will enable the selection of the commercial formulation for pediatric use of bosutinib
Taste evaluation using Bosutinib Taste Assessment Questionnaire toward formulation for pediatric use(Bosutinib mannitol high sweet)
Time frame: baseline to one month
This study will enable the selection of the commercial formulation for pediatric use of bosutinib
Taste evaluation using Bosutinib Taste Assessment Questionnaire toward formulation for pediatric use (Bosutinib mannitol in low flavour strawberry)
Time frame: baseline to one month
This study will enable the selection of the commercial formulation for pediatric use of bosutinib
Taste evaluation using Bosutinib Taste Assessment Questionnaire toward formulation for pediatric use (Bosutinib mannitol high flavour strawberry)
Time frame: baseline to one month
This study will enable the selection of the commercial formulation for pediatric use of bosutinib
Taste evaluation using Bosutinib Taste Assessment Questionnaire toward formulation for pediatric use (Bosutinib 50 mg capsules X4) low sweet
Time frame: baseline to one month
This study will enable the selection of the commercial formulation for pediatric use of bosutinib
Taste evaluation using Bosutinib Taste Assessment Questionnaire toward formulation for pediatric use (Bosutinib 50 mg capsules X4) high sweet
Time frame: baseline to one month
This study will enable the selection of the commercial formulation for pediatric use of bosutinib
Taste evaluation using Bosutinib Taste Assessment Questionnaire toward formulation for pediatric use (Bosutinib 50 mg capsules X4) low flavour
Time frame: baseline to one month
This study will enable the selection of the commercial formulation for pediatric use of bosutinib
Taste evaluation using Bosutinib Taste Assessment Questionnaire toward formulation for pediatric use (Bosutinib 50 mg capsules X4) high flavour
Time frame: baseline to one month
This study will enable the selection of the commercial formulation for pediatric use of bosutinib
Taste evaluation using Bosutinib Taste Assessment Questionnaire toward formulation for pediatric use (Bosutinib 50 mg capsules X4) applesauce
Time frame: baseline to one month
This study will enable the selection of the commercial formulation for pediatric use of bosutinib
Taste evaluation using Bosutinib Taste Assessment Questionnaire toward formulation for pediatric use (bosutinib 4 capsules 50 mg bosutinib in yogurt
Time frame: baseline to one month
This study will enable the selection of the commercial formulation for pediatric use of bosutinib
Taste evaluation using Bosutinib Taste Assessment Questionnaire toward formulation for pediatric use (Bosutinib 50 mg capsules X4 in water retest)
Time frame: baseline to one month
This study will enable the selection of the commercial formulation for pediatric use of bosutinib
14 secondary outcomes
Number or treatment emergent treatment related adverse events following oral administration of bosutinib solution bosutinib 200 mg sorbitol
Time frame: Baseline to one month
Number or treatment emergent treatment related adverse events following oral administration of 200 mg bosutinib powder mannitol solution
Time frame: baseline to one month
Number of patients with treatment emergent treatment related adverse events bosutinib 50 mg x4 capsules in water
Time frame: baseline to one month
Number of patients with treatment emergent treatment related adverse events bosutinib 200 mg mannitol low sweet
Time frame: baseline to one month
number of patients with treatment emergent or treatment related adverse events bosutinib 200 mg mannitol high sweet
Time frame: baseline to one month
number of patients with treatment emergent treatment related adverse events bosutinib 200 mg mannitol high flavour (strawberry)
Time frame: baseline to one month
Number or treatment emergent treatment related adverse events following oral administration of bosutinib 200 mg solution mannitol low flavour
Time frame: baseline to one month
Number or treatment emergent treatment related adverse events following oral administration of bosutinib solution 50 mg x 4 capsules high sweet
Time frame: baseline to one month
Number or treatment emergent treatment related adverse events following oral administration of bosutinib solution capsules 4 x 50mg low flavour
Time frame: baseline to one month
Number or treatment emergent treatment related adverse events following oral administration of bosutinib solution capsules 50 mg X4 high flavour
Time frame: baseline to one month
Number or treatment emergent treatment related adverse events following oral administration of bosutinib solution capsules 4 x 50 mg applesauce
Time frame: baseline to one month
Number or treatment emergent treatment related adverse events following oral administration of bosutinib solution capsules 50 mg x4 in yogurt
Time frame: baseline to one month
Number of treatment emergent treatment related adverse events following oral administration of 4 X50 mg capsules bosutinib low sweet solution
Time frame: baseline to one month
Number of treatment emergent treatment related adverse events following oral administration of bosutinib 50 mg capsules x4 in water (retest)
Time frame: baseline to one month
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 10 Jul 2020.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 200 Mg capsules of bosutinib in Water solution, bosunitib sorbitol and Bosutinib Mannitol in people with CML, run by Pfizer at 1 site in Belgium.
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 10 inclusion and 24 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 10 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
Taste evaluation using Bosutinib Taste Assessment Questionnaire toward formulation for pediatric use (Bosutinib in Water) (time frame: baseline to one month). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jul 2020.