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Completed

NCT Number: NCT02194244

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

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.

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Key information

Conditions

Healthy Volunteer

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Leeds, LS2 9LH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RG1662 granules

Drug

Single dose, oral administration of RG1662 immediate release granules

RG1662 tablet

Drug

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

Primary outcomes

  1. Granules Fed (test): RG1662 plasma exposure, area under the concentration-time curve

    Time frame: Up to 9 weeks

  2. Granules Fasted (test): RG1662 plasma exposure, area under the concentration-time curve

    Time frame: Up to 9 weeks

  3. Tablet Fed (reference): RG1662 plasma exposure, area under the concentration-time curve

    Time frame: Up to 9 weeks

  4. Tablet Fasted (reference): RG1662 plasma exposure, area under the concentration-time curve

    Time frame: Up to 9 weeks

Secondary outcomes

  1. Tablet formulation: RG1662 plasma exposure ratio between fed (test) and fasted (reference) conditions, estimated from area under the concentration-time curve measurements

    Time frame: Up to 9 weeks

  2. Granule formulation: RG1662 plasma exposure ratio between fed (test) and fasted (reference) conditions, estimated from area under the concentration-time curve measurements

    Time frame: Up to 9 weeks

  3. Palatability of the granule formulation, as assessed by questionnaire

    Time frame: Day 1, Day 3 in granule administration periods

  4. Safety: Incidence of adverse events with either formulation

    Time frame: Up to 9 weeks

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jul 18, 2014
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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