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Completed

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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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Nottingham, United Kingdom

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

Drug

Reference formulation, 10 milligram/milliliter (mg/mL)oral solution without sweetener/flavor.

Other names: JNJ-53718678

Formulation B

Drug

10 mg/mL oral solution containing 2 mg/mL sucralose, masking flavor and orange flavor.

Other names: JNJ-53718678

Formulation C

Drug

10 mg/mL oral solution containing 10 mg/mL sucralose.

Other names: JNJ-53718678

Formulation D

Drug

10 mg/mL oral solution containing 2 mg/mL sucralose and raspberry flavor.

Other names: JNJ-53718678

Formulation E

Drug

10 mg/mL oral solution containing 2 mg/mL sucralose and strawberry flavor.

Other names: JNJ-53718678

Formulation F

Drug

10 mg/mL oral solution containing 2 mg/mL sucralose and orange flavor.

Other names: JNJ-53718678

Formulation M1

Drug

Best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).

Other names: JNJ-53718678

Formulation M2

Drug

Best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).

Other names: JNJ-53718678

Formulation M3

Drug

Best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).

Other names: JNJ-53718678

Formulation N1

Drug

Second best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).

Other names: JNJ-53718678

Formulation N2

Drug

Second best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).

Other names: JNJ-53718678

Formulation N3

Drug

Second best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).

Other names: JNJ-53718678

Primary outcomes

  1. 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

  1. 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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