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
2 other identifiers
interventional
18
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Aug 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 8, 2014
CompletedFirst Posted
Study publicly available on registry
July 18, 2014
CompletedStudy Start
First participant enrolled
August 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedNovember 2, 2016
November 1, 2016
Same day
July 8, 2014
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (4)
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 Outcomes (4)
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
Study Arms (4)
Granules Fasted
EXPERIMENTALGranules Fed
EXPERIMENTALTablet Fasted
ACTIVE COMPARATORTablet Fed
ACTIVE COMPARATORInterventions
Single dose, oral administration of RG1662 immediate release granules
Single dose, oral administration of film-coated RG1662 immediate release tablet
Eligibility Criteria
You may qualify if:
- Male or female volunteers, 18 to 60 years of age, inclusive
You may not qualify if:
- A history of epilepsy, convulsions or significant head injury
- Any other clinically relevant abnormalities, concomitant diseases or ongoing medical conditions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Leeds, LS2 9LH, United Kingdom
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2014
First Posted
July 18, 2014
Study Start
August 1, 2014
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
November 2, 2016
Record last verified: 2016-11