The primary objective is to evaluate in a double-blinded (neither physician nor participant knows the treatment that the participant receives), fashion the taste of different JNJ-53718678 oral liquid formulations as compared to the reference formulation (JNJ-53718678, 10 milligram/milliliter oral solution without sweetener/flavor).
This is a Phase 1, double-blind, randomized (participants taste the same groups of drugs \[formulations\] but in random order), single-center trial in healthy adult participants. The study will include 2 Sessions of 1 day, 1) Session 1, in which participants will receive 6 JNJ-53718678 oral solutions (1 reference and 5 different formulations) sequentially in a randomized order, Scoring of the taste will be done via a questionnaire designed for this purpose; 2) Session 2, within approximately a timeframe of 7 to 14 days after completion of Session 1, participants will taste 2 best scoring tastes coming out of Session 1. The study will consist of a screening phase of approximately 2 weeks, treatment phase of approximately 2 weeks and a post-treatment follow-up phase of 10 days after completion of the last Session. The total study duration for each participant will be approximately 6 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
12
Reference formulation, 10 milligram/milliliter (mg/mL)oral solution without sweetener/flavor.
10 mg/mL oral solution containing 2 mg/mL sucralose, masking flavor and orange flavor.
10 mg/mL oral solution containing 10 mg/mL sucralose.
Unnamed facility
Nottingham, United Kingdom
Acceptability Score
Formulations will be assessed using Acceptability Questionnaire, which evaluates sweetness, bitterness, aroma type, aroma strength, smell and overall acceptability using visual analogue scales (VAS) with range from 0 (super bad) to 100 (super good).
Time frame: up to 12 hour post-administration of study drug
Number of Participants with Local and Systemic adverse Events
Time frame: Screening up to end of Study (Week 6)
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10 mg/mL oral solution containing 2 mg/mL sucralose and raspberry flavor.
10 mg/mL oral solution containing 2 mg/mL sucralose and strawberry flavor.
10 mg/mL oral solution containing 2 mg/mL sucralose and orange flavor.
Best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).
Best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).
Best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).
Second best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).
Second best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).
Second best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).