Healthy VolunteerPhase 1NCT01625806
A Study of The Effects of Multiple Doses of Ketoconazole on Single Dose Pharmacokinetics of RO4602522 in Healthy Male Volunteers
A Phase 1 study testing RO4602522 and ketoconazole in people with Healthy Volunteer, run by Hoffmann-La Roche at 1 site in Netherlands.
Trial summary
This single-center, open-label, parallel group study will evaluate the effects of multiple doses of ketoconazole on the pharmacokinetics of single oral dose RO4602522 in healthy male volunteers. All subjects will receive a single oral dose of RO4602522 on Day 1. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- RO4602522 and ketoconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2012to Dec 2012
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects, 18 to 45 years of age, inclusive Healthy status is defined by absence of evidence of any active or chronic disease following detailed medical and surgical history and a complete physical examination
- Body mass index (BMI) 18 to 30 kg/m2 inclusive
- Male subjects and their partners of child-bearing potential must use two methods of contraception, one of which must be a barrier method, for the duration of the study and for 90 days after the last dose
- Non-smoker (not having smoked since at least 3 months prior to screening)
Who cannot join
- History of alcohol abuse or drug addiction (including soft drugs like cannabis products)
- Positive for hepatitis B, hepatitis C, or HIV infection
- Participation in an investigational drug or device study within 90 days prior to screening
- Concomitant disease or condition that could interfere with, or treatment of which might interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
- History of any disease or condition that could alter the absorption, metabolism or elimination of drugs
- Positive drug test and/or positive alcohol test
Show all 9Show fewer
- Positive cotinine test
- Subject likely to need concomitant medication during the study period (including for dental conditions)
- Any confirmed significant allergic reactions against any drug, or multiple allergies in the judgment of the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Center, Open-Label, Parallel Study to Investigate the Effects of Multiple Doses of Ketoconazole on the Pharmacokinetics of a Single Oral Dose of RO4602522 in Healthy Male Subjects
This single-center, open-label, parallel group study will evaluate the effects of multiple doses of ketoconazole on the pharmacokinetics of single oral dose RO4602522 in healthy male volunteers. All subjects will receive a single oral dose of RO4602522 on Day 1. Subjects assigned to Group 2 will additionally receive ketoconazole (200 mg orally every 12 hours) from Day 1 to Day 17.
- Conditions
- Healthy Volunteer
- Being tested
- RO4602522, ketoconazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO4602522Drug
Single oral dose
ketoconazoleDrug
Multiple oral doses
| Study group | Role | What they receive |
|---|---|---|
| RO4602522 | Active comparator | Not described Receives: Drug: RO4602522 |
| RO4602522 + ketoconazole | Experimental | Not described Receives: Drug: RO4602522; Drug: ketoconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of multiple doses of ketoconazole on RO4602522 single dose pharmacokinetics: Area under the concentration-time curve (AUC)
Measured: Pre-dose and up to 10 hrs post-dose Day 1, and on Days 2-22
Secondary outcomes (2)
Safety: Incidence of adverse events
Measured: approximately 3 months
RO4602522 metabolites: Plasma/urine concentrations
Measured: Pre-dose and up to 10 hrs post-dose Day 1, and on Days 2-22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2012
- Study completionDec 2012
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 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
- NCT01625806
- Sponsor's protocol ID
- BP28236
- Other IDs
- 2012-001195-11
- Status last verified
- Nov 2016
- First submitted
- 19 Jun 2012
- 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 Single-Center, Open-Label, Parallel Study to Investigate the Effects of Multiple Doses of Ketoconazole on the Pharmacokinetics of a Single Oral Dose of RO4602522 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01625806
- Acronym / sponsor ID
- BP28236
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 21 Jun 2012 (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, parallel group study will evaluate the effects of multiple doses of ketoconazole on the pharmacokinetics of single oral dose RO4602522 in healthy male volunteers. All subjects will receive a single oral dose of RO4602522 on Day 1. Subjects assigned to Group 2 will additionally receive ketoconazole (200 mg orally every 12 hours) from Day 1 to Day 17.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RO4602522 | Active comparator | Drug: RO4602522 |
| RO4602522 + ketoconazole | Experimental | Drug: RO4602522, Drug: ketoconazole |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male subjects, 18 to 45 years of age, inclusive Healthy status is defined by absence of evidence of any active or chronic disease following detailed medical and surgical history and a complete physical examination
- Body mass index (BMI) 18 to 30 kg/m2 inclusive
- Male subjects and their partners of child-bearing potential must use two methods of contraception, one of which must be a barrier method, for the duration of the study and for 90 days after the last dose
- Non-smoker (not having smoked since at least 3 months prior to screening)
Key exclusion criteria (9 listed)
- History of alcohol abuse or drug addiction (including soft drugs like cannabis products)
- Positive for hepatitis B, hepatitis C, or HIV infection
- Participation in an investigational drug or device study within 90 days prior to screening
- Concomitant disease or condition that could interfere with, or treatment of which might interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study
- History of any disease or condition that could alter the absorption, metabolism or elimination of drugs
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 |
|---|---|---|
| RO4602522Single oral dose | Drug | RO4602522, RO4602522 + ketoconazole |
| ketoconazoleMultiple oral doses | Drug | RO4602522 + ketoconazole |
Primary outcome
Effect of multiple doses of ketoconazole on RO4602522 single dose pharmacokinetics: Area under the concentration-time curve (AUC)
Time frame: Pre-dose and up to 10 hrs post-dose Day 1, and on Days 2-22
2 secondary outcomes
Safety: Incidence of adverse events
Time frame: approximately 3 months
RO4602522 metabolites: Plasma/urine concentrations
Time frame: Pre-dose and up to 10 hrs post-dose Day 1, and on Days 2-22
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 RO4602522 and ketoconazole 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 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 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?
Effect of multiple doses of ketoconazole on RO4602522 single dose pharmacokinetics: Area under the concentration-time curve (AUC) (time frame: Pre-dose and up to 10 hrs post-dose Day 1, and on Days 2-22). 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.