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

Healthy Volunteer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02194244
• Other study ID #: WP28978
• Secondary ID: 2014-001762-97
• Status: Completed
• Phase: Phase 1
• First received: July 8, 2014
• Last updated: November 1, 2016
• Start date: August 2014
• Est. completion date: August 2014

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• RG1662 granules
Single dose, oral administration of RG1662 immediate release granules
• RG1662 tablet
Single dose, oral administration of film-coated RG1662 immediate release tablet

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Granules Fed (test): RG1662 plasma exposure, area under the concentration-time curve		Up to 9 weeks	No
Primary	Granules Fasted (test): RG1662 plasma exposure, area under the concentration-time curve		Up to 9 weeks	No
Primary	Tablet Fed (reference): RG1662 plasma exposure, area under the concentration-time curve		Up to 9 weeks	No
Primary	Tablet Fasted (reference): RG1662 plasma exposure, area under the concentration-time curve		Up to 9 weeks	No
Secondary	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	No
Secondary	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	No
Secondary	Palatability of the granule formulation, as assessed by questionnaire		Day 1, Day 3 in granule administration periods	No
Secondary	Safety: Incidence of adverse events with either formulation		Up to 9 weeks	No