Study to Assess the Taste Profile of Different ALS-008176 Oral Liquid Formulations in Healthy Adult Participants

PHASE1CompletedINTERVENTIONAL
Enrollment

11

Participants

Timeline

Start Date

June 30, 2016

Primary Completion Date

August 31, 2016

Study Completion Date

August 31, 2016

Conditions
Healthy
Interventions
DRUG

Formulation A (ALS-008176)

Reference formulation, 60 mg/mL ALS-008176 oral suspension without sweetener/flavor.

DRUG

Formulation B (ALS-008176)

60 mg/mL ALS-008176 oral suspension containing 12 mg/mL sucralose.

DRUG

Formulation C (ALS-008176)

60 mg/mL ALS-008176 oral suspension containing 4 mg/mL sucralose and strawberry flavor.

DRUG

Formulation D (ALS-008176)

60 mg/mL ALS-008176 oral suspension containing 4 mg/mL sucralose and masking flavor and strawberry flavor.

DRUG

Formulation E (ALS-008176)

60 mg/mL ALS-008176 oral suspension containing 4 mg/mL sucralose and masking flavor and cream vanille flavor.

DRUG

Formulation F (ALS-008176)

60 mg/mL ALS-008176 oral suspension containing 4 mg/mL sucralose and fantasy fruit flavor.

DRUG

Formulation G1 (ALS-008176)

60 mg/mL ALS-008176 oral suspension with concentration 1 of sucralose (maximum 12 mg/mL) and best flavor 1 from session 1.

DRUG

Formulation G2 (ALS-008176)

60 mg/mL ALS-008176 oral suspension with concentration 2 of sucralose (maximum 12 mg/mL) and best flavor 1 from session 1.

DRUG

Formulation G3 (ALS-008176)

60 mg/mL ALS-008176 oral suspension with concentration 3 of sucralose (maximum 12 mg/mL) and best flavor 1 from session 1.

DRUG

Formulation H1 (ALS-008176)

60 mg/mL ALS-008176 oral suspension with concentration 1 of sucralose (maximum 12 mg/mL) and best flavor 2 from session 1.

DRUG

Formulation H2 (ALS-008176)

60 mg/mL ALS-008176 oral suspension with concentration 2 of sucralose (maximum 12 mg/mL) and best flavor 2 from session 1.

DRUG

Formulation H3 (ALS-008176)

60 mg/mL ALS-008176 oral suspension with concentration 3 of sucralose (maximum 12 mg/mL) and best flavor 2 from session 1.

Trial Locations (1)

Unknown

Nottingham

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT02813460 - Study to Assess the Taste Profile of Different ALS-008176 Oral Liquid Formulations in Healthy Adult Participants | Biotech Hunter | Biotech Hunter