Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2014-001762-97 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Granules Fasted | Experimental |
| |
| Granules Fed | Experimental |
| |
| Tablet Fasted | Active Comparator |
| |
| Tablet Fed | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RG1662 granules | Drug | Single dose, oral administration of RG1662 immediate release granules |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leeds | LS2 9LH | United Kingdom |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| RG1662 tablet | Drug | Single dose, oral administration of film-coated RG1662 immediate release tablet |
|
| 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 |