Healthy Patient StudyPhase 1NCT02470832
A Study to Investigate the Effect of CYP3A Inhibition on the Pharmacokinetics of RG1662 in Healthy Subjects
A Phase 1 study testing RG1662 and itraconazole in people with Healthy Patient Study, run by Hoffmann-La Roche at 1 site in United Kingdom.
Trial summary
The study is being conducted to investigate the effect of itraconazole treatment in the pharmacokinetics of RG1662. It is also to evaluate the exposure of RG1662 vs. QTc response relationship and the safety and tolerability of RG1662 when given in combination with itraconazole in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Patient Study
- What is being tested?
- RG1662 and itraconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2015to Jul 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
- Male or female volunteers
- Ages 18 to 60 years, inclusive
- A body mass index (BMI) between 18 to 32 kg/m2, inclusive
- Agreement to comply with study restrictions
Who cannot join
- History of epilepsy, convulsions or significant head injury or electroencephalogram (EEG) abnormalities
- Electrocardiogram (EGC) or vital signs abnormalities
- Significant history of drug allergy, as determined by the Investigator, or a known hypersensitivity to any of the ingredients of any of the study treatments
- Use of any drugs or substances that are known to be substrates, inducers or inhibitors of CYP3A4 within 30 days of the first dose administration
- Pregnant or lactating
- Any other clinically relevant abnormalities, concomitant diseases or ongoing medical conditions
Trial locations and contacts
1 site in 1 country.
About this study
The study is being conducted to investigate the effect of itraconazole treatment in the pharmacokinetics of RG1662. It is also to evaluate the exposure of RG1662 vs. QTc response relationship and the safety and tolerability of RG1662 when given in combination with itraconazole in healthy subjects.
- Conditions
- Healthy Patient Study
- Being tested
- RG1662, itraconazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RG1662Drug
itraconazoleDrug
| Study group | Role | What they receive |
|---|---|---|
| Combination therapy RG1662 + itraconazole | Experimental | Days 20-29: Oral administration RG1662 twice daily within 30 minutes of a meal + 2 x 100 mg itraconazole once daily with food Receives: Drug: RG1662; Drug: itraconazole |
| RG1662 Monotherapy | Experimental | Days 1-10: RG1662 120 mg twice daily (b.i.d.) within 30 minutes of a meal for 10 days (Days 1 to 9, Day 10 only a.m. dose). (Cohort A subjects will receive 1 x 120 mg RG1662 tablets twice daily. In Cohorts B and C the dose of RG1662 will be decided upon following review of the interim safety and pharmacokinetic data of the 4 subjects in Cohort A.) Receives: Drug: RG1662 |
| itraconazole Monotherapy | Experimental | Days 15-19: 200 mg of itraconazole twice daily for 5 days (Days 15 to 18, Day 19 only a.m. dose) Receives: Drug: itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-time curve from 0-t (AUC0-t)
Measured: Within 29 days
Maximum observed plasma concentration (Cmax)
Measured: Within 29 days
Time to maximum observed plasma concentration (Tmax)
Measured: Within 29 days
Secondary outcomes (4)
Change from baseline in QTcF
Measured: Up to 29 days
Incidence of adverse events
Measured: Within 43 days
Clinically significant changes from baseline in physical examination or laboratory parameters
Measured: Within 29 days
Mean model parameters of RG1662 concentration vs. QTcF changes
Measured: Within 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2015 (estimated)
- Study startMay 2015
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Patient StudyStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 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
- NCT02470832
- Sponsor's protocol ID
- WP29402
- Other IDs
- 2015-000261-31, 2015
- Status last verified
- Aug 2016
- First submitted
- 13 May 2015
- Last updated
- 26 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Investigate the Effect of CYP3A Inhibition on the Pharmacokinetics of RG1662 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02470832
- Acronym / sponsor ID
- WP29402
- Conditions
- Healthy Patient Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 12 Jun 2015 (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.
The study is being conducted to investigate the effect of itraconazole treatment in the pharmacokinetics of RG1662. It is also to evaluate the exposure of RG1662 vs. QTc response relationship and the safety and tolerability of RG1662 when given in combination with itraconazole in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Combination therapy RG1662 + itraconazole | Experimental | Drug: RG1662, Drug: itraconazoleDays 20-29: Oral administration RG1662 twice daily within 30 minutes of a meal + 2 x 100 mg itraconazole once daily with food |
| RG1662 Monotherapy | Experimental | Drug: RG1662Days 1-10: RG1662 120 mg twice daily (b.i.d.) within 30 minutes of a meal for 10 days (Days 1 to 9, Day 10 only a.m. dose). (Cohort A subjects will receive 1 x 120 mg RG1662 tablets twice daily. In Cohorts B and C the dose of RG1662 will be decided upon following review of the interim safety and pharmacokinetic data of the 4 subjects in Cohort A.) |
| itraconazole Monotherapy | Experimental | Drug: itraconazoleDays 15-19: 200 mg of itraconazole twice daily for 5 days (Days 15 to 18, Day 19 only a.m. dose) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male or female volunteers
- Ages 18 to 60 years, inclusive
- A body mass index (BMI) between 18 to 32 kg/m2, inclusive
- Agreement to comply with study restrictions
Key exclusion criteria (6 listed)
- History of epilepsy, convulsions or significant head injury or electroencephalogram (EEG) abnormalities
- Electrocardiogram (EGC) or vital signs abnormalities
- Significant history of drug allergy, as determined by the Investigator, or a known hypersensitivity to any of the ingredients of any of the study treatments
- Use of any drugs or substances that are known to be substrates, inducers or inhibitors of CYP3A4 within 30 days of the first dose administration
- Pregnant or lactating
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 | Drug | Combination therapy RG1662 + itraconazole, RG1662 Monotherapy |
| itraconazole | Drug | Combination therapy RG1662 + itraconazole, itraconazole Monotherapy |
Primary outcome
Area under the plasma concentration-time curve from 0-t (AUC0-t)
Time frame: Within 29 days
Maximum observed plasma concentration (Cmax)
Time frame: Within 29 days
Time to maximum observed plasma concentration (Tmax)
Time frame: Within 29 days
4 secondary outcomes
Change from baseline in QTcF
Time frame: Up to 29 days
Incidence of adverse events
Time frame: Within 43 days
Clinically significant changes from baseline in physical examination or laboratory parameters
Time frame: Within 29 days
Mean model parameters of RG1662 concentration vs. QTcF changes
Time frame: Within 29 days
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 26 Aug 2016.
Related trials for Healthy Patient Study
RecruitingPhase 2
Hematopoietic Stem Cell Mobilization in Idiopathic CD4 Lymphocytopenia Patients and Healthy Controls for the Study of T Cell Maturation and Trafficking in Murine Models
Idiopathic CD4-Positive, T-Lymphocytopenia
Not yet recruitingObservational study
Screening Protocol
Pain
RecruitingObservational study
Studies of Skin Microbes in Healthy People and in People With Skin Conditions
Eczema, Atopic Dermatitis
RecruitingPhase 1
FIH Study to Evaluate the Tolerability of PF-07832837 in Healthy Adults and Patients
Healthy Participants, Atopic Dermatitis
RecruitingObservational study
Kidney Stiffness Measured by Ultrasound in Patients With High Blood Pressure and Healthy Volunteers
Arterial Hypertension, Chronic Kidney Disease, Primary Aldosteronism
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 and itraconazole in people with Healthy Patient Study, 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 4 inclusion and 6 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 26 Aug 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?
Area under the plasma concentration-time curve from 0-t (AUC0-t) (time frame: Within 29 days). The study lists 3 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 26 Aug 2016.