Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02426632 | Study to Evaluate Taste Profile of Different JNJ-53718678 Oral Liquid Formulations in Healthy Participants | PHASE1 | COMPLETED | 12 | — | — | Mar 4, 2015 | Apr 24, 2015 | May 15, 2018 | 1 | United Kingdom |
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).
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| Formulation A | DRUG | Reference formulation, 10 milligram/milliliter (mg/mL)oral solution without sweetener/flavor. |
| Formulation B | DRUG | 10 mg/mL oral solution containing 2 mg/mL sucralose, masking flavor and orange flavor. |
| Formulation C | DRUG | 10 mg/mL oral solution containing 10 mg/mL sucralose. |
| Formulation D | DRUG | 10 mg/mL oral solution containing 2 mg/mL sucralose and raspberry flavor. |
| Formulation E | DRUG | 10 mg/mL oral solution containing 2 mg/mL sucralose and strawberry flavor. |
| Formulation F | DRUG | 10 mg/mL oral solution containing 2 mg/mL sucralose and orange flavor. |
| Formulation M1 | DRUG | Best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL). |
| Formulation M2 | DRUG | Best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL). |
| Formulation M3 | DRUG | Best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL). |
| Formulation N1 | DRUG | Second best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL). |
| Formulation N2 | DRUG | Second best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL). |
| Formulation N3 | DRUG | Second best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL). |
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 adher...