Palatability (Taste) of Oral Formulations of Bosutinib

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

Interventions

DRUG

200 Mg capsules of bosutinib in Water solution

200 mg (4X50) Capsules in water

DRUG

bosunitib sorbitol

200 Mg of bosutinib sorbitol solution

DRUG

Bosutinib Mannitol

Bosutinib mannitol solution

DRUG

bosutinib in mannitol low sweet

bosutinib in mannitol solution low sweet

DRUG

bosutinib in mannitol high sweet

bosutinib in mannitol high sweet

DRUG

bosutinib taste low flavour

bosutinib solution low flavour

DRUG

bosutinib high flavour

bosutinib solution high flavour

DRUG

bosutinib capsules in applesauce

Bosutinib capsules in applesauce

DRUG

Bosutinib capsules in yogurt

bosutinib capsules in yogurt

DRUG

bosutinib capsules in water

sham comparator, bosutinb in water retest

DRUG

Bosutinib capsules in low sweet

bosutinib capsules in low sweet

DRUG

bosutinib capsules high sweet

Bosutinib capsules high sweet

DRUG

bosutinib capsules low flavour

Bosutinib capsules low flavour

DRUG

bosutinib capsules high flavour

bosutinib capsules in high flavour

Sponsors & Collaborators

• Pfizer

  lead INDUSTRY

Principal Investigators

• Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-11-22

Primary Completion

2019-01-14

Completion

2019-01-14

Countries

• Belgium

Study Locations