Healthy VolunteerPhase 1NCT02295332
A Study of RG7625 in Healthy Volunteers
A Phase 1 study testing RG7625 in people with Healthy Volunteer, run by Hoffmann-La Roche at 1 site in Netherlands.
Trial summary
This is a single center, randomized, double-blind, placebo-controlled, single ascending dose study that will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic effects of single doses of RG7625 in healthy male and female volunteers. 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?
- RG7625
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2014to Apr 2015
- 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
- Healthy male and female participants, 18 to 60 years of age, inclusive
- A body mass index between 18 to 30 kg/m2 inclusive
- Able to participate and willing to give written informed consent and to comply with the study restrictions
Who cannot join
- Any clinically relevant abnormalities, concomitant diseases or ongoing medical conditions, abnormal laboratory test results or a history of any other clinically significant disorders
- Any major illness within the one month preceding the screening visit, or any febrile illness within the two weeks preceding the screening visit
- Any significant allergic reaction to drugs
- Immunocompromised or with reduced immune function and/or immunization within 30 days before the first study drug administration or planning vaccination during the study
- Women who are pregnant or lactating or of childbearing potential
- Clinically significant abnormal ECG or other risk factors for QT prolongation
- Use of prescribed or over the counter medication
- Inability or unwillingness to comply with study requirements
Trial locations and contacts
1 site in 1 country.
About this study
This is a single center, randomized, double-blind, placebo-controlled, single ascending dose study that will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic effects of single doses of RG7625 in healthy male and female volunteers.
The study will employ an interleaved cohort ('leapfrog') design in which dosing is alternated between two cohorts and each individual within a cohort will receive study drug dosing on four occasions - in effect giving a four treatment, four period, four-way crossover for each individual. The minimum duration for each participant is approximately 8 weeks.
- Conditions
- Healthy Volunteer
- Being tested
- Placebo, RG7625
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Matching oral placebo capsules to RG7625, according to treatment schedule
RG7625Drug
oral administration, capsules, single ascending dose according to treatment schedule
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | Not described Receives: Drug: Placebo; Drug: RG7625 |
| Cohort B | Experimental | Not described Receives: Drug: Placebo; Drug: RG7625 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety (composite outcome measure):Incidence and severity of adverse events (AEs), laboratory abnormalities, changes in ECG, vital signs
Measured: Approximately 22 weeks
Secondary outcomes (2)
Pharmacokinetics (composite outcome measure): PK profile and parameters derived from plasma concentrations of RG7625 and its metabolites [AUCinf, AUClast, Cmax, tmax, t1/2, CL/F, V/F, Ae, fe and CLR]
Measured: 22 weeks
Pharmacodynamics (composite outcome measure): measurement of intracellular p10 concentrations and cell surface expression of major histocompatibility complex class (MHC)-II, relationship to RG7625 exposure
Measured: 22 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study startDec 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 17 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
- NCT02295332
- Sponsor's protocol ID
- WP29542
- Other IDs
- 2014-003538-23, 2014
- Status last verified
- Nov 2016
- First submitted
- 17 Nov 2014
- Last updated
- 2 Nov 2016
- Results posted
- No
Publications
Theron M, Bentley D, Nagel S, Manchester M, Gerg M, Schindler T, Silva A, Ecabert B, Teixeira P, Perret C, Reis B. Pharmacodynamic Monitoring of RO5459072, a Small Molecule Inhibitor of Cathepsin S. Front Immunol. 2017 Jul 17;8:806. doi: 10.3389/fimmu.2017.00806. eCollection 2017.
PubMed 28769925
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 Study of RG7625 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02295332
- Acronym / sponsor ID
- WP29542
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 20 Nov 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 is a single center, randomized, double-blind, placebo-controlled, single ascending dose study that will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic effects of single doses of RG7625 in healthy male and female volunteers.
The study will employ an interleaved cohort ('leapfrog') design in which dosing is alternated between two cohorts and each individual within a cohort will receive study drug dosing on four occasions - in effect giving a four treatment, four period, four-way crossover for each individual. The minimum duration for each participant is approximately 8 weeks.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Drug: Placebo, Drug: RG7625 |
| Cohort B | Experimental | Drug: Placebo, Drug: RG7625 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male and female participants, 18 to 60 years of age, inclusive
- A body mass index between 18 to 30 kg/m2 inclusive
- Able to participate and willing to give written informed consent and to comply with the study restrictions
Key exclusion criteria (8 listed)
- Any clinically relevant abnormalities, concomitant diseases or ongoing medical conditions, abnormal laboratory test results or a history of any other clinically significant disorders
- Any major illness within the one month preceding the screening visit, or any febrile illness within the two weeks preceding the screening visit
- Any significant allergic reaction to drugs
- Immunocompromised or with reduced immune function and/or immunization within 30 days before the first study drug administration or planning vaccination during the study
- Women who are pregnant or lactating or of childbearing potential
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 |
|---|---|---|
| PlaceboMatching oral placebo capsules to RG7625, according to treatment schedule | Drug | Cohort A, Cohort B |
| RG7625oral administration, capsules, single ascending dose according to treatment schedule | Drug | Cohort A, Cohort B |
Primary outcome
Safety (composite outcome measure):Incidence and severity of adverse events (AEs), laboratory abnormalities, changes in ECG, vital signs
Time frame: Approximately 22 weeks
2 secondary outcomes
Pharmacokinetics (composite outcome measure): PK profile and parameters derived from plasma concentrations of RG7625 and its metabolites [AUCinf, AUClast, Cmax, tmax, t1/2, CL/F, V/F, Ae, fe and CLR]
Time frame: 22 weeks
Pharmacodynamics (composite outcome measure): measurement of intracellular p10 concentrations and cell surface expression of major histocompatibility complex class (MHC)-II, relationship to RG7625 exposure
Time frame: 22 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.
- Derived from this study: PubMed 28769925Theron M, Bentley D, Nagel S, Manchester M, Gerg M, Schindler T, Silva A, Ecabert B, Teixeira P, Perret C, Reis B. Pharmacodynamic Monitoring of RO5459072, a Small Molecule Inhibitor of Cathepsin S. Front Immunol. 2017 Jul 17;8:806. doi: 10.3389/fimmu.2017.00806. eCollection 2017.
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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 RG7625 in people with Healthy Volunteer, run by Hoffmann-La Roche at 1 site in Netherlands.
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 3 inclusion and 8 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 Netherlands. 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?
Safety (composite outcome measure):Incidence and severity of adverse events (AEs), laboratory abnormalities, changes in ECG, vital signs (time frame: Approximately 22 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02295332, which also lists 1 linked publication.
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.