NCT02426632

Study to Evaluate Taste Profile of Different JNJ-53718678 Oral Liquid Formulations in Healthy Participants

A Phase 1, Double-blind, Randomized, Trial to Evaluate the Taste Profile of Different JNJ-53718678 Oral Liquid Formulations in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Janssen Sciences Ireland UC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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).

Detailed description

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Formulation A	Reference formulation, 10 milligram/milliliter (mg/mL)oral solution without sweetener/flavor.
DRUG	Formulation B	10 mg/mL oral solution containing 2 mg/mL sucralose, masking flavor and orange flavor.
DRUG	Formulation C	10 mg/mL oral solution containing 10 mg/mL sucralose.
DRUG	Formulation D	10 mg/mL oral solution containing 2 mg/mL sucralose and raspberry flavor.
DRUG	Formulation E	10 mg/mL oral solution containing 2 mg/mL sucralose and strawberry flavor.
DRUG	Formulation F	10 mg/mL oral solution containing 2 mg/mL sucralose and orange flavor.
DRUG	Formulation M1	Best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).
DRUG	Formulation M2	Best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).
DRUG	Formulation M3	Best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).
DRUG	Formulation N1	Second best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).
DRUG	Formulation N2	Second best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).
DRUG	Formulation N3	Second best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).

Timeline

• Start date: 2015-03-04
• Primary completion: 2015-04-24
• Completion: 2015-04-24
• First posted: 2015-04-27
• Last updated: 2018-05-15

Locations

1 site across 1 country: United Kingdom