Healthy VolunteerPhase 1NCT01873508
A Study of Three Modified-Release Formulations of RO4917523 in Healthy Volunteers
A Phase 1 study testing RO4917523 in people with Healthy Volunteer, run by Hoffmann-La Roche at 1 site in United States.
Trial summary
This single-center, open label, randomized, 3-period cross-over study will compare 3 modified-release formulations of RO4917523 in healthy volunteers. Subjects will be randomized to one of six sequences to receive single oral doses of RO4917523 slow, target and fast release modified release (MR) capsules along with a… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- RO4917523
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Aug 2013
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female volunteers, 18 - 55 years of age inclusive Healthy status will be defined by absence in evidence of any active or chronic disease following a detailed medical and surgical history and a complete physical examination
- Body mass index (BMI) of 18 to 30 kg/m2, inclusive, and body weight of at least 50 kg
- Females of child-bearing potential must agree to use effective contraception as defined by protocol
- Non-smoker for at least 90 days prior to dosing on Day 1
Who cannot join
- History or presence of a clinically significant psychiatric condition as defined by protocol
- Participation in an clinical study with an investigational drug within 60 days or 5 times the half-life (whichever is longer) preceding first administration of study drug. Participation in more than 3 other drug studies within 10 months preceding first administration of study drug.
- Clinically significant disease or disorder
- Personal or family history of long QT syndrome or sudden death
- Any suspicion or history of alcohol and/or other substance abuse or dependence in the last 6 months
- Subject likely to need concomitant medication during the study (including for dental conditions), except for hormonal contraception or HRT
Show all 9Show fewer
- Pregnant or lactating women, or women who intend to become pregnant during the course of the study
- Positive for hepatitis B, hepatitis C or HIV infection
- Any confirmed significant allergic reactions against any drug, or multiple allergies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Open Label, Randomized Cross-over Study to Compare 3 Modified-release Formulations With Different Release Profiles of RO4917523 Along With a Reference Intravenous Microdose Infusion
This single-center, open label, randomized, 3-period cross-over study will compare 3 modified-release formulations of RO4917523 in healthy volunteers. Subjects will be randomized to one of six sequences to receive single oral doses of RO4917523 slow, target and fast release modified release (MR) capsules along with a reference intravenous microdose with the target capsule. A washout period of at least 21 days will occur between treatments.
- Conditions
- Healthy Volunteer
- Being tested
- RO4917523
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO4917523Drug
Fast release MR capsule, single dose
RO4917523Drug
Target release MR capsule, single dose
RO4917523Drug
Slow release MR capsule, single dose
RO4917523Drug
[13C]-labeled tracer dose i.v.
| Study group | Role | What they receive |
|---|---|---|
| Fast release MR capsule | Experimental | Not described Receives: Drug: RO4917523 |
| Slow release MR capsule | Experimental | Not described Receives: Drug: RO4917523 |
| Target release MR capsule | Experimental | Not described Receives: Drug: RO4917523 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics: Area under the concentration-time curve (AUC)
Measured: Pre-dose and up to 144 hours post-dose
Pharmacokinetics: Maximum concentration (Cmax)
Measured: Pre-dose and up to 144 hours post-dose
Secondary outcomes (7)
Pharmacokinetics: Time to maximum plasma concentration (tmax)
Measured: Pre-dose and up to 144 hours post-dose
Pharmacokinetics: Elimination half-life (t1/2)
Measured: Pre-dose and up to 144 hours post-dose
Pharmacokinetics: Elimination rate constant: (kel)
Measured: Pre-dose and up to 144 hours post-dose
Pharmacokinetics: Absolute bioavailability (F)
Measured: Pre-dose and up to 144 hours post-dose
Pharmacokinetics: Total body clearance (CL)
Measured: Pre-dose and up to 144 hours post-dose
Pharmacokinetics: Volume of distribution (Vd)
Measured: Pre-dose and up to 144 hours post-dose
Safety: Incidence of adverse events
Measured: approximately 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionAug 2013
- Study completionAug 2013
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
- 24 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
- NCT01873508
- Sponsor's protocol ID
- NP28738
- Other IDs
- 2013-000502-28
- Status last verified
- Sep 2015
- First submitted
- 6 Jun 2013
- Last updated
- 10 Sep 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open Label, Randomized Cross-over Study to Compare 3 Modified-release Formulations With Different Release Profiles of RO4917523 Along With a Reference Intravenous Microdose Infusion
- ClinicalTrials.gov ID
- NCT01873508
- Acronym / sponsor ID
- NP28738
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 10 Jun 2013 (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 single-center, open label, randomized, 3-period cross-over study will compare 3 modified-release formulations of RO4917523 in healthy volunteers. Subjects will be randomized to one of six sequences to receive single oral doses of RO4917523 slow, target and fast release modified release (MR) capsules along with a reference intravenous microdose with the target capsule. A washout period of at least 21 days will occur between treatments.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fast release MR capsule | Experimental | Drug: RO4917523 |
| Slow release MR capsule | Experimental | Drug: RO4917523 |
| Target release MR capsule | Experimental | Drug: RO4917523 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male and female volunteers, 18 - 55 years of age inclusive Healthy status will be defined by absence in evidence of any active or chronic disease following a detailed medical and surgical history and a complete physical examination
- Body mass index (BMI) of 18 to 30 kg/m2, inclusive, and body weight of at least 50 kg
- Females of child-bearing potential must agree to use effective contraception as defined by protocol
- Non-smoker for at least 90 days prior to dosing on Day 1
Key exclusion criteria (9 listed)
- History or presence of a clinically significant psychiatric condition as defined by protocol
- Participation in an clinical study with an investigational drug within 60 days or 5 times the half-life (whichever is longer) preceding first administration of study drug. Participation in more than 3 other drug studies within 10 months preceding first administration of study drug.
- Clinically significant disease or disorder
- Personal or family history of long QT syndrome or sudden death
- Any suspicion or history of alcohol and/or other substance abuse or dependence in the last 6 months
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 |
|---|---|---|
| RO4917523Fast release MR capsule, single dose | Drug | Fast release MR capsule |
| RO4917523Target release MR capsule, single dose | Drug | Target release MR capsule |
| RO4917523Slow release MR capsule, single dose | Drug | Slow release MR capsule |
| RO4917523[13C]-labeled tracer dose i.v. | Drug | Target release MR capsule |
Primary outcome
Pharmacokinetics: Area under the concentration-time curve (AUC)
Time frame: Pre-dose and up to 144 hours post-dose
Pharmacokinetics: Maximum concentration (Cmax)
Time frame: Pre-dose and up to 144 hours post-dose
7 secondary outcomes
Pharmacokinetics: Time to maximum plasma concentration (tmax)
Time frame: Pre-dose and up to 144 hours post-dose
Pharmacokinetics: Elimination half-life (t1/2)
Time frame: Pre-dose and up to 144 hours post-dose
Pharmacokinetics: Elimination rate constant: (kel)
Time frame: Pre-dose and up to 144 hours post-dose
Pharmacokinetics: Absolute bioavailability (F)
Time frame: Pre-dose and up to 144 hours post-dose
Pharmacokinetics: Total body clearance (CL)
Time frame: Pre-dose and up to 144 hours post-dose
Pharmacokinetics: Volume of distribution (Vd)
Time frame: Pre-dose and up to 144 hours post-dose
Safety: Incidence of adverse events
Time frame: approximately 13 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 10 Sep 2015.
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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 RO4917523 in people with Healthy Volunteer, run by Hoffmann-La Roche at 1 site in United States.
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 4 inclusion and 9 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 10 Sep 2015. 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 States. 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?
Pharmacokinetics: Area under the concentration-time curve (AUC) (time frame: Pre-dose and up to 144 hours post-dose). The study lists 2 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 10 Sep 2015.