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

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 Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: RG1662 granules; Drug: RG1662 tablet

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Leeds, United Kingdom, LS2 9LH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: July 8, 2014
• First Submitted That Met QC Criteria: July 16, 2014
• First Posted (Estimate): July 18, 2014

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: WP28978; 2014-001762-97 (EudraCT Number)