Palatability (Taste) of Oral Formulations of Bosutinib
Condition: CML
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): 200 Mg capsules of bosutinib in Water solution; bosunitib sorbitol; Bosutinib Mannitol; bosutinib in mannitol low sweet; bosutinib in mannitol high sweet; bosutinib taste low flavour; bosutinib high flavour; bosutinib capsules in applesauce; Bosutinib capsules in yogurt; bosutinib capsules in water; Bosutinib capsules in low sweet; bosutinib capsules high sweet; bosutinib capsules low flavour; bosutinib capsules high flavour
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 200 mg (4X50) Capsules in water; 200 Mg of bosutinib sorbitol solution; Bosutinib mannitol solution; bosutinib in mannitol solution low sweet; bosutinib in mannitol high sweet; bosutinib solution low flavour; bosutinib solution high flavour; Bosutinib capsules in applesauce; bosutinib capsules in yogurt; sham comparator, bosutinb in water retest; bosutinib capsules in low sweet; Bosutinib capsules high sweet; Bosutinib capsules low flavour; bosutinib capsules in high flavour
Intervention MeSH terms: Mannitol; Sorbitol
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention 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 (Participant)
Primary purpose: Other
Keywords: CML; palatability; taste; pediatric formulation