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Trial record 2 of 9 for:    rg1662

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

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ClinicalTrials.gov Identifier: NCT02194244
Recruitment Status : Completed
First Posted : July 18, 2014
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: RG1662 granules Drug: RG1662 tablet Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
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
Study Start Date : August 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02194244


Locations
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United Kingdom
Leeds, United Kingdom, LS2 9LH
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02194244     History of Changes
Other Study ID Numbers: WP28978
2014-001762-97 ( EudraCT Number )
First Posted: July 18, 2014    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016