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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02813460 | Study to Assess the Taste Profile of Different ALS-008176 Oral Liquid Formulations in Healthy Adult Participants | PHASE1 | COMPLETED | 11 | — | — | Jun 1, 2016 | Aug 1, 2016 | Feb 3, 2025 | 1 | United Kingdom |
Taste will be assessed using a questionnaire designed for the purpose. The questionnaire will consist of a visual analogue scale to rate 5 items (sweetness, bitterness, aroma type, aroma strength, and smell) as well as overall acceptability.
| Arm | Type | Description |
|---|---|---|
| Session 1: Sequence 1 | EXPERIMENTAL | Participants will sequentially receive 5 milliliters (mL) of each 6 ALS-008176 formulations A B F C E D on day 1. |
| Session 1: Sequence 2 | EXPERIMENTAL | Participants will sequentially receive 5 mL of each 6 ALS-008176 formulations B C A D F E on day 1. |
| Session 1: Sequence 3 | EXPERIMENTAL | Participants will sequentially receive 5 mL of each 6 ALS-008176 formulations C D B E A F on day 1. |
| Session 1: Sequence 4 | EXPERIMENTAL | Participants will sequentially receive 5 mL of each 6 ALS-008176 formulations D E C F B A on day 1. |
| Session 1: Sequence 5 | EXPERIMENTAL | Participants will sequentially receive 5 mL of each 6 ALS-008176 formulations E F D A C B on day 1. |
| Session 1: Sequence 6 | EXPERIMENTAL | Participants will sequentially receive 5 mL of each 6 ALS-008176 formulations F A E B D C on day 1. |
| Session 2: Sequence 1 | EXPERIMENTAL | Participants will receive 5 mL of two best scoring formulations from Session 1 with 3 varying concentrations of sucralose (G1 G2 H3 G3 H2 H1). |
| Session 2: Sequence 2 | EXPERIMENTAL | Participants will receive 5 mL of two best scoring formulations from Session 1 with 3 varying concentrations of sucralose (G2 G3 G1 H1 H3 H2). |
| Session 2: Sequence 3 | EXPERIMENTAL | Participants will receive 5 mL of two best scoring formulations from Session 1 with 3 varying concentrations of sucralose (G3 H1 G2 H2 G1 H3). |
| Session 2: Sequence 4 | EXPERIMENTAL | Participants will receive 5 mL of two best scoring formulations from Session 1 with 3 varying concentrations of sucralose (H1 H2 G3 H3 G2 G1). |
| Session 2: Sequence 5 | EXPERIMENTAL | Participants will receive 5 mL of two best scoring formulations from Session 1 with 3 varying concentrations of sucralose (H2 H3 H1 G1 G3 G2). |
| Session 2: Sequence 6 | EXPERIMENTAL | Participants will receive 5 mL of two best scoring formulations from Session 1 with 3 varying concentrations of sucralose (H3 G1 H2 G2 H1 G3). |
| Name | Type | Description |
|---|---|---|
| Formulation A (ALS-008176) | DRUG | Reference formulation, 60 mg/mL ALS-008176 oral suspension without sweetener/flavor. |
| Formulation B (ALS-008176) | DRUG | 60 mg/mL ALS-008176 oral suspension containing 12 mg/mL sucralose. |
| Formulation C (ALS-008176) | DRUG | 60 mg/mL ALS-008176 oral suspension containing 4 mg/mL sucralose and strawberry flavor. |
| Formulation D (ALS-008176) | DRUG | 60 mg/mL ALS-008176 oral suspension containing 4 mg/mL sucralose and masking flavor and strawberry flavor. |
| Formulation E (ALS-008176) | DRUG | 60 mg/mL ALS-008176 oral suspension containing 4 mg/mL sucralose and masking flavor and cream vanille flavor. |
| Formulation F (ALS-008176) | DRUG | 60 mg/mL ALS-008176 oral suspension containing 4 mg/mL sucralose and fantasy fruit flavor. |
| Formulation G1 (ALS-008176) | DRUG | 60 mg/mL ALS-008176 oral suspension with concentration 1 of sucralose (maximum 12 mg/mL) and best flavor 1 from session 1. |
| Formulation G2 (ALS-008176) | DRUG | 60 mg/mL ALS-008176 oral suspension with concentration 2 of sucralose (maximum 12 mg/mL) and best flavor 1 from session 1. |
| Formulation G3 (ALS-008176) | DRUG | 60 mg/mL ALS-008176 oral suspension with concentration 3 of sucralose (maximum 12 mg/mL) and best flavor 1 from session 1. |
| Formulation H1 (ALS-008176) | DRUG | 60 mg/mL ALS-008176 oral suspension with concentration 1 of sucralose (maximum 12 mg/mL) and best flavor 2 from session 1. |
| Formulation H2 (ALS-008176) | DRUG | 60 mg/mL ALS-008176 oral suspension with concentration 2 of sucralose (maximum 12 mg/mL) and best flavor 2 from session 1. |
| Formulation H3 (ALS-008176) | DRUG | 60 mg/mL ALS-008176 oral suspension with concentration 3 of sucralose (maximum 12 mg/mL) and best flavor 2 from session 1. |
Inclusion Criteria: * Participant must be a man or woman between 18 and 65 years of age, inclusive, at Screening * Participant must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the s...