Healthy VolunteerPhase 1NCT02194244
Comparative Bioavailability Study of Film-coated Tablet and Granule Formulations of RG1662
A Phase 1 study testing RG1662 granules and RG1662 tablet in people with Healthy Volunteer, run by Hoffmann-La Roche at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- RG1662 granules and RG1662 tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2014to Aug 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female volunteers, 18 to 60 years of age, inclusive
Who cannot join
- A history of epilepsy, convulsions or significant head injury
- Any other clinically relevant abnormalities, concomitant diseases or ongoing medical conditions
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Healthy Volunteer
- Being tested
- RG1662 granules, RG1662 tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RG1662 granulesDrug
Single dose, oral administration of RG1662 immediate release granules
RG1662 tabletDrug
Single dose, oral administration of film-coated RG1662 immediate release tablet
| Study group | Role | What they receive |
|---|---|---|
| Granules Fasted | Experimental | Not described Receives: Drug: RG1662 granules |
| Granules Fed | Experimental | Not described Receives: Drug: RG1662 granules |
| Tablet Fasted | Active comparator | Not described Receives: Drug: RG1662 tablet |
| Tablet Fed | Active comparator | Not described Receives: Drug: RG1662 tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Granules Fed (test): RG1662 plasma exposure, area under the concentration-time curve
Measured: Up to 9 weeks
Granules Fasted (test): RG1662 plasma exposure, area under the concentration-time curve
Measured: Up to 9 weeks
Tablet Fed (reference): RG1662 plasma exposure, area under the concentration-time curve
Measured: Up to 9 weeks
Tablet Fasted (reference): RG1662 plasma exposure, area under the concentration-time curve
Measured: 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
Measured: 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
Measured: Up to 9 weeks
Palatability of the granule formulation, as assessed by questionnaire
Measured: Day 1, Day 3 in granule administration periods
Safety: Incidence of adverse events with either formulation
Measured: Up to 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2014 (estimated)
- Study startAug 2014
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02194244
- Sponsor's protocol ID
- WP28978
- Other IDs
- 2014-001762-97, 2014
- Status last verified
- Nov 2016
- First submitted
- 8 Jul 2014
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02194244
- Acronym / sponsor ID
- WP28978
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 18 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Granules Fasted | Experimental | Drug: RG1662 granules |
| Granules Fed | Experimental | Drug: RG1662 granules |
| Tablet Fasted | Active comparator | Drug: RG1662 tablet |
| Tablet Fed | Active comparator | Drug: RG1662 tablet |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Male or female volunteers, 18 to 60 years of age, inclusive
Key exclusion criteria (2 listed)
- A history of epilepsy, convulsions or significant head injury
- Any other clinically relevant abnormalities, concomitant diseases or ongoing medical conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RG1662 granulesSingle dose, oral administration of RG1662 immediate release granules | Drug | Granules Fasted, Granules Fed |
| RG1662 tabletSingle dose, oral administration of film-coated RG1662 immediate release tablet | Drug | Tablet Fasted, Tablet Fed |
Primary outcome
Granules Fed (test): RG1662 plasma exposure, area under the concentration-time curve
Time frame: Up to 9 weeks
Granules Fasted (test): RG1662 plasma exposure, area under the concentration-time curve
Time frame: Up to 9 weeks
Tablet Fed (reference): RG1662 plasma exposure, area under the concentration-time curve
Time frame: Up to 9 weeks
Tablet Fasted (reference): RG1662 plasma exposure, area under the concentration-time curve
Time frame: Up to 9 weeks
4 secondary outcomes
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
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
Palatability of the granule formulation, as assessed by questionnaire
Time frame: Day 1, Day 3 in granule administration periods
Safety: Incidence of adverse events with either formulation
Time frame: Up to 9 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RG1662 granules and RG1662 tablet in people with Healthy Volunteer, run by Hoffmann-La Roche at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Granules Fed (test): RG1662 plasma exposure, area under the concentration-time curve (time frame: Up to 9 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.