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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Formulation F; Drug: Formulation N1; Drug: Formulation D; Drug: Formulation C; Drug: Formulation M2; Drug: Formulation E; Drug: Formulation M1; Drug: Formulation M3; Drug: Formulation N2; Drug: Formulation B; Drug: Formulation N3; Drug: Formulation A

Study type: Interventional

Funder types: Industry

Identifiers

NCT02426632

CR106726

2014-005157-39 (EudraCT Number)

53718678RSV1003 (Other Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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12 participants in 12 patient groups

Session 1: Sequence 1

Experimental group

Description:

Participants will sequentially receive 5 milliliter of each 6 JNJ-53718678 formulations (ABCDEF) in a random order, at a dosing interval of 1-2 hours.

Treatment:

Drug: Formulation A

Drug: Formulation D

Drug: Formulation B

Drug: Formulation E

Drug: Formulation C

Drug: Formulation F

Session 1: Sequence 2

Experimental group

Description:

Participants will sequentially receive 5 milliliter of each 6 JNJ-53718678 formulations (ABCDEF) in a random order, at a dosing interval of 1-2 hours.

Treatment:

Drug: Formulation A

Drug: Formulation D

Drug: Formulation B

Drug: Formulation E

Drug: Formulation C

Drug: Formulation F

Session 1: Sequence 3

Experimental group

Description:

Participants will sequentially receive 5 milliliter of each 6 JNJ-53718678 formulations (ABCDEF) in a random order, at a dosing interval of 1-2 hours.

Treatment:

Drug: Formulation A

Drug: Formulation D

Drug: Formulation B

Drug: Formulation E

Drug: Formulation C

Drug: Formulation F

Session 1: Sequence 4

Experimental group

Description:

Participants will sequentially receive 5 milliliter of each 6 JNJ-53718678 formulations (ABCDEF) in a random order, at a dosing interval of 1-2 hours.

Treatment:

Drug: Formulation A

Drug: Formulation D

Drug: Formulation B

Drug: Formulation E

Drug: Formulation C

Drug: Formulation F

Session 1: Sequence 5

Experimental group

Description:

Participants will sequentially receive 5 milliliter of each 6 JNJ-53718678 formulations (ABCDEF) in a random order, at a dosing interval of 1-2 hours.

Treatment:

Drug: Formulation A

Drug: Formulation D

Drug: Formulation B

Drug: Formulation E

Drug: Formulation C

Drug: Formulation F

Session 1: Sequence 6

Experimental group

Description:

Participants will sequentially receive 5 milliliter of each 6 JNJ-53718678 formulations (ABCDEF) in a random order, at a dosing interval of 1-2 hours.

Treatment:

Drug: Formulation A

Drug: Formulation D

Drug: Formulation B

Drug: Formulation E

Drug: Formulation C

Drug: Formulation F

Session 2: Sequence 7

Experimental group

Description:

Participants will receive two best scoring formulations from Session 1 with a varying concentration of sucralose (M1M2M3N1N2N3) sequentially in a random order, at a dosing interval of 1-2 hours.

Treatment:

Drug: Formulation N3

Drug: Formulation N2

Drug: Formulation M3

Drug: Formulation M1

Drug: Formulation M2

Drug: Formulation N1

Session 2: Sequence 8

Experimental group

Description:

Participants will receive two best scoring formulations from Session 1 with a varying concentration of sucralose (M1M2M3N1N2N3) sequentially in a random order, at a dosing interval of 1-2 hours.

Treatment:

Drug: Formulation N3

Drug: Formulation N2

Drug: Formulation M3

Drug: Formulation M1

Drug: Formulation M2

Drug: Formulation N1

Session 2: Sequence 9

Experimental group

Description:

Participants will receive two best scoring formulations from Session 1 with a varying concentration of sucralose (M1M2M3N1N2N3) sequentially in a random order, at a dosing interval of 1-2 hours.

Treatment:

Drug: Formulation N3

Drug: Formulation N2

Drug: Formulation M3

Drug: Formulation M1

Drug: Formulation M2

Drug: Formulation N1

Session 2: Sequence 10

Experimental group

Description:

Participants will receive two best scoring formulations from Session 1 with a varying concentration of sucralose (M1M2M3N1N2N3) sequentially in a random order, at a dosing interval of 1-2 hours.

Treatment:

Drug: Formulation N3

Drug: Formulation N2

Drug: Formulation M3

Drug: Formulation M1

Drug: Formulation M2

Drug: Formulation N1

Session 2: Sequence 11

Experimental group

Description:

Participants will receive two best scoring formulations from Session 1 with a varying concentration of sucralose (M1M2M3N1N2N3) sequentially in a random order, at a dosing interval of 1-2 hours.

Treatment:

Drug: Formulation N3

Drug: Formulation N2

Drug: Formulation M3

Drug: Formulation M1

Drug: Formulation M2

Drug: Formulation N1

Session 2: Sequence 12

Experimental group

Description:

Participants will receive two best scoring formulations from Session 1 with a varying concentration of sucralose (M1M2M3N1N2N3) sequentially in a random order, at a dosing interval of 1-2 hours.

Treatment:

Drug: Formulation N3

Drug: Formulation N2

Drug: Formulation M3

Drug: Formulation M1

Drug: Formulation M2

Drug: Formulation N1