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

NCT02426632 | Completed Phase 1

• 3 other identifiers: CR10672653718678RSV10032014-005157-39
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Healthy; JNJ-53718678

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Participants with Local and Systemic adverse Events

  Screening up to end of Study (Week 6)

Study Arms (12)

Session 1: Sequence 1

EXPERIMENTAL

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.

Drug: Formulation A; Drug: Formulation B; Drug: Formulation C; Drug: Formulation D; Drug: Formulation E; Drug: Formulation F

Session 1: Sequence 2

EXPERIMENTAL

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.

Drug: Formulation A; Drug: Formulation B; Drug: Formulation C; Drug: Formulation D; Drug: Formulation E; Drug: Formulation F

Session 1: Sequence 3

EXPERIMENTAL

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.

Drug: Formulation A; Drug: Formulation B; Drug: Formulation C; Drug: Formulation D; Drug: Formulation E; Drug: Formulation F

Session 1: Sequence 4

EXPERIMENTAL

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.

Drug: Formulation A; Drug: Formulation B; Drug: Formulation C; Drug: Formulation D; Drug: Formulation E; Drug: Formulation F

Session 1: Sequence 5

EXPERIMENTAL

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.

Drug: Formulation A; Drug: Formulation B; Drug: Formulation C; Drug: Formulation D; Drug: Formulation E; Drug: Formulation F

Session 1: Sequence 6

EXPERIMENTAL

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.

Drug: Formulation A; Drug: Formulation B; Drug: Formulation C; Drug: Formulation D; Drug: Formulation E; Drug: Formulation F

Session 2: Sequence 7

EXPERIMENTAL

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.

Drug: Formulation M1; Drug: Formulation M2; Drug: Formulation M3; Drug: Formulation N1; Drug: Formulation N2; Drug: Formulation N3

Session 2: Sequence 8

EXPERIMENTAL

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.

Drug: Formulation M1; Drug: Formulation M2; Drug: Formulation M3; Drug: Formulation N1; Drug: Formulation N2; Drug: Formulation N3

Session 2: Sequence 9

EXPERIMENTAL

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.

Drug: Formulation M1; Drug: Formulation M2; Drug: Formulation M3; Drug: Formulation N1; Drug: Formulation N2; Drug: Formulation N3

Session 2: Sequence 10

EXPERIMENTAL

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.

Drug: Formulation M1; Drug: Formulation M2; Drug: Formulation M3; Drug: Formulation N1; Drug: Formulation N2; Drug: Formulation N3

Session 2: Sequence 11

EXPERIMENTAL

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.

Drug: Formulation M1; Drug: Formulation M2; Drug: Formulation M3; Drug: Formulation N1; Drug: Formulation N2; Drug: Formulation N3

Session 2: Sequence 12

EXPERIMENTAL

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.

Drug: Formulation M1; Drug: Formulation M2; Drug: Formulation M3; Drug: Formulation N1; Drug: Formulation N2; Drug: Formulation N3

Interventions

Formulation A DRUG

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

Also known as: JNJ-53718678

Session 1: Sequence 1; Session 1: Sequence 2; Session 1: Sequence 3; Session 1: Sequence 4; Session 1: Sequence 5; Session 1: Sequence 6

Formulation B DRUG

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

Also known as: JNJ-53718678

Session 1: Sequence 1; Session 1: Sequence 2; Session 1: Sequence 3; Session 1: Sequence 4; Session 1: Sequence 5; Session 1: Sequence 6

Formulation C DRUG

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

Also known as: JNJ-53718678

Session 1: Sequence 1; Session 1: Sequence 2; Session 1: Sequence 3; Session 1: Sequence 4; Session 1: Sequence 5; Session 1: Sequence 6

Formulation D DRUG

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

Also known as: JNJ-53718678

Session 1: Sequence 1; Session 1: Sequence 2; Session 1: Sequence 3; Session 1: Sequence 4; Session 1: Sequence 5; Session 1: Sequence 6

Formulation E DRUG

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

Also known as: JNJ-53718678

Session 1: Sequence 1; Session 1: Sequence 2; Session 1: Sequence 3; Session 1: Sequence 4; Session 1: Sequence 5; Session 1: Sequence 6

Formulation F DRUG

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

Also known as: JNJ-53718678

Session 1: Sequence 1; Session 1: Sequence 2; Session 1: Sequence 3; Session 1: Sequence 4; Session 1: Sequence 5; Session 1: Sequence 6

Formulation M1 DRUG

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

Also known as: JNJ-53718678

Session 2: Sequence 10; Session 2: Sequence 11; Session 2: Sequence 12; Session 2: Sequence 7; Session 2: Sequence 8; Session 2: Sequence 9

Formulation M2 DRUG

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

Also known as: JNJ-53718678

Session 2: Sequence 10; Session 2: Sequence 11; Session 2: Sequence 12; Session 2: Sequence 7; Session 2: Sequence 8; Session 2: Sequence 9

Formulation M3 DRUG

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

Also known as: JNJ-53718678

Session 2: Sequence 10; Session 2: Sequence 11; Session 2: Sequence 12; Session 2: Sequence 7; Session 2: Sequence 8; Session 2: Sequence 9

Formulation N1 DRUG

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

Also known as: JNJ-53718678

Session 2: Sequence 10; Session 2: Sequence 11; Session 2: Sequence 12; Session 2: Sequence 7; Session 2: Sequence 8; Session 2: Sequence 9

Formulation N2 DRUG

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

Also known as: JNJ-53718678

Session 2: Sequence 10; Session 2: Sequence 11; Session 2: Sequence 12; Session 2: Sequence 7; Session 2: Sequence 8; Session 2: Sequence 9

Formulation N3 DRUG

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

Also known as: JNJ-53718678

Session 2: Sequence 10; Session 2: Sequence 11; Session 2: Sequence 12; Session 2: Sequence 7; Session 2: Sequence 8; Session 2: Sequence 9

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Sciences Ireland UC: lead

Study Sites (1)

Unknown Facility

Nottingham, United Kingdom

Location

MeSH Terms

Interventions

JNJ-53718678; D-Worm; Granuflex E

Study Officials

• Janssen Sciences Ireland UC Clinical Trial

  Janssen Sciences Ireland UC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2015
• First Posted: April 27, 2015
• Study Start: March 4, 2015
• Primary Completion: April 24, 2015
• Study Completion: April 24, 2015
• Last Updated: May 15, 2018

Record last verified: 2018-05

Locations

GB (1)