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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02426632
• Other study ID #: CR106726
• Secondary ID: 53718678RSV10032
• Status: Completed
• Phase: Phase 1
• Start date: March 4, 2015
• Est. completion date: April 24, 2015

Study information

• Verified date: May 2018
• Source: Janssen Sciences Ireland UC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 24, 2015
• Est. primary completion date: April 24, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Sciences Ireland UC

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability Score	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).	up to 12 hour post-administration of study drug
Secondary	Number of Participants with Local and Systemic adverse Events		Screening up to end of Study (Week 6)