Comparative Bioavailability Study of Film-coated Tablet and Granule Formulations of RG1662

Study Overview
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Brief Summary
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This study will compare the pharmacokinetic performance of film-coated tablet and granule formulations of RG1662 under fed and fasted conditions in healthy volunteers. A randomized, four-period, four-treatment crossover design is used. In each period, each volunteer will receive a single oral dose of the tablet or granule formulation either with or without food.

Official Title
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A Randomized, Open-Label, Four Period, Four-Treatment Crossover Study to Investigate the Comparative Bioavailability of Film-Coated Tablet and Granule Formulations of RG1662 Under Fed and Fasted Conditions in Healthy Volunteers

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: RG1662 granules
* Drug: RG1662 tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female volunteers, 18 to 60 years of age, inclusive Exclusion Criteria: A history of epilepsy, convulsions or significant head injury Any other clinically relevant abnormalities, concomitant diseases or ongoing medical conditions

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Granules Fasted<br> | Drug: RG1662 granules<br>* Single dose, oral administration of RG1662 immediate release granules<br>|
| Experimental: Granules Fed<br> | Drug: RG1662 granules<br>* Single dose, oral administration of RG1662 immediate release granules<br>|
| Active Comparator: Tablet Fasted<br> | Drug: RG1662 tablet<br>* Single dose, oral administration of film-coated RG1662 immediate release tablet<br>|
| Active Comparator: Tablet Fed<br> | Drug: RG1662 tablet<br>* Single dose, oral administration of film-coated RG1662 immediate release tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Granules Fed (test): RG1662 plasma exposure, area under the concentration-time curve |  | Up to 9 weeks | 
| Granules Fasted (test): RG1662 plasma exposure, area under the concentration-time curve |  | Up to 9 weeks | 
| Tablet Fed (reference): RG1662 plasma exposure, area under the concentration-time curve |  | Up to 9 weeks | 
| Tablet Fasted (reference): RG1662 plasma exposure, area under the concentration-time curve |  | Up to 9 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tablet formulation: RG1662 plasma exposure ratio between fed (test) and fasted (reference) conditions, estimated from area under the concentration-time curve measurements |  | Up to 9 weeks | 
| Granule formulation: RG1662 plasma exposure ratio between fed (test) and fasted (reference) conditions, estimated from area under the concentration-time curve measurements |  | Up to 9 weeks | 
| Palatability of the granule formulation, as assessed by questionnaire |  | Day 1, Day 3 in granule administration periods | 
| Safety: Incidence of adverse events with either formulation |  | Up to 9 weeks |