NCT03747679

Palatability (Taste) of Oral Formulations of Bosutinib

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-11-22
• Primary completion: 2019-01-14
• Completion: 2019-01-14
• First posted: 2018-11-20
• Last updated: 2020-07-10

Locations

1 site across 1 country: Belgium