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
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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