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

Summary

The purpose of this study is to evaluate in a double-blinded fashion the taste and overall acceptability profile of different ALS-008176 oral liquid formulations as compared to the reference formulation (ALS-008176: 60 milligram per milliliters (mg/mL) oral suspension without sweetener/flavor) for pediatric clinical development and commercialization.

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.

Sponsors & Collaborators

• Janssen Research & Development, LLC

  lead INDUSTRY

Principal Investigators

• Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-06-30

Primary Completion

2016-08-31

Completion

2016-08-31

Countries

• United Kingdom

Study Locations