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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
18
Single dose, oral administration of RG1662 immediate release granules
Single dose, oral administration of film-coated RG1662 immediate release tablet
Unnamed facility
Leeds, United Kingdom
Granules Fed (test): RG1662 plasma exposure, area under the concentration-time curve
Time frame: Up to 9 weeks
Granules Fasted (test): RG1662 plasma exposure, area under the concentration-time curve
Time frame: Up to 9 weeks
Tablet Fed (reference): RG1662 plasma exposure, area under the concentration-time curve
Time frame: Up to 9 weeks
Tablet Fasted (reference): RG1662 plasma exposure, area under the concentration-time curve
Time frame: Up to 9 weeks
Tablet formulation: RG1662 plasma exposure ratio between fed (test) and fasted (reference) conditions, estimated from area under the concentration-time curve measurements
Time frame: 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
Time frame: Up to 9 weeks
Palatability of the granule formulation, as assessed by questionnaire
Time frame: Day 1, Day 3 in granule administration periods
Safety: Incidence of adverse events with either formulation
Time frame: Up to 9 weeks
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