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

NCT02426632 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2018-05-15

No results posted yet for this study

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).

Conditions

  • Healthy

Interventions

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).

Sponsors & Collaborators

  • Janssen Sciences Ireland UC

    lead INDUSTRY

Principal Investigators

  • Janssen Sciences Ireland UC Clinical Trial · Janssen Sciences Ireland UC

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-03-04
Primary Completion
2015-04-24
Completion
2015-04-24

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02426632 on ClinicalTrials.gov