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

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: RG1662 tablet; Drug: RG1662 granules

• Registration Number: NCT02194244
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-08
• Study First Submitted QC: 2014-07-16
• Study First Posted: 2014-07-18
• Study Start: 2014-08
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Tablet Fed	RG1662 tablet	-
Granules Fasted	RG1662 granules	-
Granules Fed	RG1662 granules	-
Tablet Fasted	RG1662 tablet	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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