Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Formulation G1 · 1 trial · 1 indication
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...
Formulation G1 is an investigational small molecule being studied in healthy adult participants. It is part of a clinical trial assessing the taste profile of different oral liquid formulations. The study is not intended to treat a disease but to evaluate the formulation's sensory characteristics in healthy volunteers.
Formulation G1 is being developed by Johnson & Johnson (NYSE: JNJ). The company is conducting a Phase 1 clinical trial to evaluate the taste profile of this oral liquid formulation in healthy participants.
Formulation G1 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing study is a completed Phase 1 trial that enrolled 11 healthy adult participants in the United Kingdom.
Formulation G1 is associated with one completed Phase 1 clinical trial, NCT02813460, titled 'Study to Assess the Taste Profile of Different ALS-008176 Oral Liquid Formulations in Healthy Adult Participants.' The trial enrolled 11 healthy adults in the United Kingdom and was randomized, double-blind, and controlled.
Formulation G1 is one of several oral liquid formulations of the compound ALS-008176 evaluated in the clinical trial. The study compares the taste profiles of different formulations, with Formulation G1 being one of the variants tested in healthy participants.