Palatability (Taste) of Oral Formulations of Bosutinib

NCT03747679 | Completed Phase 1

• 3 other identifiers: B18710572018-002346-37BCHILD TASTE
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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. Approximately 8 participants will assess the sensory attributes of different powder for oral suspension (POS) formulations.

Conditions

CML

Keywords

CML; palatability; taste; pediatric formulation

Outcome Measures

Primary Outcomes (14)

• 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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  Baseline to one month

• Number or treatment emergent treatment related adverse events following oral administration of 200 mg bosutinib powder mannitol solution

  baseline to one month

• Number of patients with treatment emergent treatment related adverse events bosutinib 50 mg x4 capsules in water

  baseline to one month

• Number of patients with treatment emergent treatment related adverse events bosutinib 200 mg mannitol low sweet

  baseline to one month

• number of patients with treatment emergent or treatment related adverse events bosutinib 200 mg mannitol high sweet

  baseline to one month

Study Arms (14)

A- Bosutinib in water

EXPERIMENTAL

200 Mg of bosutinib (50 mg capsule x4) in Water solution

Drug: 200 Mg capsules of bosutinib in Water solution

B- bosutinib in sorbitol

EXPERIMENTAL

200 Mg of bosutinib sorbitol base in water solution

Drug: bosunitib sorbitol

C- - bosutinib mannitol

EXPERIMENTAL

200 Mg of bosutinib powder mannitol base in water solution

Drug: Bosutinib Mannitol

D - bosutinib in mannitol low sweet

EXPERIMENTAL

200 Mg of bosutinib mannitol low sweet solution

Drug: bosutinib in mannitol low sweet

E- - bosutinib in mannitol high sweet

EXPERIMENTAL

200 Mg of bosutinib High % sweet mannitol solution

Drug: bosutinib in mannitol high sweet

F- - bosutinib low flavour

EXPERIMENTAL

Taste assessment of 200 Mg of bosutinib low % Flavour

Drug: bosutinib taste low flavour

G- bosutinib high flavour

EXPERIMENTAL

Taste assessment of 200 Mg of bosutinib high percentage of flavor in water

Drug: bosutinib high flavour

H- - bosutinib capsules in low sweet

EXPERIMENTAL

Taste assessment of 200 Mg of bosutinib (50 mg x4 capsules) low % sweet

Drug: Bosutinib capsules in low sweet

I - bosutinib capsules high sweet

EXPERIMENTAL

200 Mg of bosutinib (4 X 50 mg capsules)in high % sweetener

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

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

Drug: bosutinib capsules high flavour

L - bosutinib capsules applesauce

EXPERIMENTAL

200 Mg of bosutinib (50 mg x 4 capsules) in applesauce

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

Drug: Bosutinib capsules in yogurt

N - bosutinib capsules in water (retest)

EXPERIMENTAL

200 Mg of bosutinib (50 mg x 4 capsules) in Water (retest)

Drug: bosutinib capsules in water

Interventions

200 Mg capsules of bosutinib in Water solution DRUG

200 mg (4X50) Capsules in water

A- Bosutinib in water

bosunitib sorbitol DRUG

200 Mg of bosutinib sorbitol solution

B- bosutinib in sorbitol

Bosutinib Mannitol DRUG

Bosutinib mannitol solution

C- - bosutinib mannitol

bosutinib in mannitol low sweet DRUG

bosutinib in mannitol solution low sweet

D - bosutinib in mannitol low sweet

bosutinib in mannitol high sweet DRUG

bosutinib in mannitol high sweet

E- - bosutinib in mannitol high sweet

bosutinib taste low flavour DRUG

bosutinib solution low flavour

F- - bosutinib low flavour

bosutinib high flavour DRUG

bosutinib solution high flavour

G- bosutinib high flavour

bosutinib capsules in applesauce DRUG

Bosutinib capsules in applesauce

L - bosutinib capsules applesauce

Bosutinib capsules in yogurt DRUG

bosutinib capsules in yogurt

M - bosutinib capsules full fat yougurt

bosutinib capsules in water DRUG

sham comparator, bosutinb in water retest

N - bosutinib capsules in water (retest)

Bosutinib capsules in low sweet DRUG

bosutinib capsules in low sweet

H- - bosutinib capsules in low sweet

bosutinib capsules high sweet DRUG

Bosutinib capsules high sweet

I - bosutinib capsules high sweet

bosutinib capsules low flavour DRUG

Bosutinib capsules low flavour

J- - bosutinib capsules low flavour

bosutinib capsules high flavour DRUG

bosutinib capsules in high flavour

K - bosutinib capsules high flavour

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Clinical Research Unit

Brussels, B-1070, Belgium

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

bosutinib

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: single blind
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: November 14, 2018
• First Posted: November 20, 2018
• Study Start: November 22, 2018
• Primary Completion: January 14, 2019
• Study Completion: January 14, 2019
• Last Updated: July 10, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)