Nottingham, United Kingdom
NCT Number: NCT02426632
Study to Evaluate Taste Profile of Different JNJ-53718678 Oral Liquid Formulations in Healthy Participants
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).
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Notify MeKey information
Conditions
Age range
18 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Female participants of childbearing potential should have a urine pregnancy test at screening which should be negative
- Participants must be non-smokers and/or have not used chewing tobacco for at least one month prior to screening
- Participants must be willing/able to adhere to the prohibitions and restrictions specified in the protocol and study procedures
- Participants must be able to taste and smell normally, to their own opinion, at all times throughout the study duration. Participants who have an impaired sense of taste and/or smell due to any conditions like common cold or sinusitis are not eligible to take part or to continue to study
- Participants must agree to use an adequate method of contraception
Exclusion criteria
- Participant has a mouth pathology including, but not limited to, pain, ulcer, edema, mucosal erosion, and/or (dental) abscesses, or receives treatment for oral pathologies or oral treatment for any disease
- Participant has a history of any illness that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant or that could prevent, limit or confound the protocol specified assessments. This may include but is not limited to renal dysfunction, significant cardiac, vascular, pulmonary, gastrointestinal (such as significant diarrhea, gastric stasis, or constipation that in the Investigator's opinion could influence drug absorption or bioavailability), endocrine, neurologic, hematologic, rheumatologic, psychiatric, neoplastic, or metabolic disturbances
- Participants with a history of clinically significant allergies, hypersensitivity, or intolerance to drugs such as, but not limited to, sulfonamides and penicillins, drug allergy witnessed in previous studies with experimental drugs, or to JNJ-53718678 or its excipients
- Participants with a history or evidence of use of alcohol, barbiturates, amphetamines, recreational or narcotic drug use within the past 3 months, which in the Investigator's opinion would compromise participant's safety and/or compliance with the study procedures
- Participants having received an investigational drug (including investigational vaccines) or used an invasive investigational device within 3 months before the planned first dose of study drugs or is currently enrolled in an investigational study
Treatment and study plan
Formulation A
DrugReference formulation, 10 milligram/milliliter (mg/mL)oral solution without sweetener/flavor.
Other names: JNJ-53718678
Formulation B
Drug10 mg/mL oral solution containing 2 mg/mL sucralose, masking flavor and orange flavor.
Other names: JNJ-53718678
Formulation C
Drug10 mg/mL oral solution containing 10 mg/mL sucralose.
Other names: JNJ-53718678
Formulation D
Drug10 mg/mL oral solution containing 2 mg/mL sucralose and raspberry flavor.
Other names: JNJ-53718678
Formulation E
Drug10 mg/mL oral solution containing 2 mg/mL sucralose and strawberry flavor.
Other names: JNJ-53718678
Formulation F
Drug10 mg/mL oral solution containing 2 mg/mL sucralose and orange flavor.
Other names: JNJ-53718678
Formulation M1
DrugBest scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).
Other names: JNJ-53718678
Formulation M2
DrugBest scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).
Other names: JNJ-53718678
Formulation M3
DrugBest scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).
Other names: JNJ-53718678
Formulation N1
DrugSecond best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).
Other names: JNJ-53718678
Formulation N2
DrugSecond best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).
Other names: JNJ-53718678
Formulation N3
DrugSecond best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).
Other names: JNJ-53718678
Primary outcomes
-
Acceptability Score
Time frame: up to 12 hour post-administration of study drug
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).
Secondary outcomes
-
Number of Participants with Local and Systemic adverse Events
Time frame: Screening up to end of Study (Week 6)
Sponsors and collaborators
Lead sponsor
Janssen Sciences Ireland UC
Industry
Registry information
Official study title
A Phase 1, Double-blind, Randomized, Trial to Evaluate the Taste Profile of Different JNJ-53718678 Oral Liquid Formulations in Healthy Subjects
Important dates
- Study start
- 2015
- Primary completion
- 2015
- Study completion
- 2015
- First posted
- Apr 27, 2015
- Registry last updated
- May 15, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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