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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02194244

Enrollment

Registered

2014-07-18

Start date

2014-08-31

Completion date

2014-08-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

Brief summary

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.

Interventions

DRUGRG1662 granules

Single dose, oral administration of RG1662 immediate release granules

DRUGRG1662 tablet

Single dose, oral administration of film-coated RG1662 immediate release tablet

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Tablet Fasted (reference): RG1662 plasma exposure, area under the concentration-time curve	Up to 9 weeks
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

Secondary

Measure	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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026