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| ID | Type | Description | Link |
|---|---|---|---|
| 53718678RSV1003 | Other Identifier | Janssen Sciences Ireland UC | |
| 2014-005157-39 | EudraCT Number |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Formulation A | Drug | Reference formulation, 10 milligram/milliliter (mg/mL)oral solution without sweetener/flavor. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Local and Systemic adverse Events | Screening up to end of Study (Week 6) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Sciences Ireland UC Clinical Trial | Janssen Sciences Ireland UC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nottingham | United Kingdom |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| Formulation B | Drug | 10 mg/mL oral solution containing 2 mg/mL sucralose, masking flavor and orange flavor. |
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| Formulation C | Drug | 10 mg/mL oral solution containing 10 mg/mL sucralose. |
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| Formulation D | Drug | 10 mg/mL oral solution containing 2 mg/mL sucralose and raspberry flavor. |
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| Formulation E | Drug | 10 mg/mL oral solution containing 2 mg/mL sucralose and strawberry flavor. |
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| Formulation F | Drug | 10 mg/mL oral solution containing 2 mg/mL sucralose and orange flavor. |
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| Formulation M1 | Drug | Best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL). |
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| Formulation M2 | Drug | Best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL). |
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| Formulation M3 | Drug | Best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL). |
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| Formulation N1 | Drug | Second best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL). |
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| Formulation N2 | Drug | Second best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL). |
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| Formulation N3 | Drug | Second best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL). |
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| ID | Term |
|---|---|
| C000624632 | JNJ-53718678 |
| C000605651 | D-Worm |
| C087325 | Granuflex E |
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