Drug-Drug InteractionPhase 1NCT02887443
A Study to Assess the Potential for Pre-systemic Inhibition of CYP3A by Idebenone Using Midazolam as a Substrate
A Phase 1 study testing Raxone (idebenone 150 mg) and Midazolam 2,5 mg in people with Drug-Drug Interaction, run by Santhera Pharmaceuticals at 1 site in France.
Trial summary
This phase I open label study is conducted to assess the potential pharmacokinetic interaction of Raxone® with midazolam in healthy male volunteers Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Drug-Drug Interaction
- What is being tested?
- Raxone (idebenone 150 mg) and Midazolam 2,5 mg
- Type of treatment
- Pill or oral medicine
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2016to Nov 2016
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male aged 18 to 55 years.
- A Body Mass Index (BMI) of 18-30. BMI = Body weight (kg) / Height (m)2.
- Male subject willing to use an acceptable effective contraceptive measure for the entire duration of study participation.
- No clinically significant abnormal serum biochemistry, haematology and urine examination values.
- A negative urinary test for drugs of abuse and alcohol breath screen. A positive alcohol test may be repeated at the discretion of the Investigator.
- Negative HIV and Hepatitis B and C results.
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- No clinically significant abnormalities in 12 lead electrocardiogram (ECG).
- No clinically significant abnormalities in blood pressure, pulse or oral temperature.
- No allergy or sensitivity to midazolam, idebenone or any of their excipients.
- No current or past medical condition that might significantly affect the pharmacokinetic or pharmacodynamic response to midazolam.
- Subject must be available to complete the study (including follow-up visit).
- Subject must satisfy a medical examiner about their fitness to participate in the study.
- Subject must provide written informed consent to participate in the study.
- Covered by Health Insurance System and/or in compliance with the recommendations of National Law in force relating to biomedical research.
Who cannot join
- A clinically significant history of gastrointestinal disorder likely to influence drug absorption.
- Use of any medication (prescription or OTC, including health supplements and herbal remedies, except paracetamol, within 2 weeks or 5 half-lives (whichever is longer) prior to the first dose of trial medication.
- Use of any medication known to induce or inhibit any of the enzymes within the CYP3A system within 28 days of Day 1, or grapefruit within 7 days of Day 1
- Evidence of renal, hepatic dysfunction, cardiovascular or metabolic dysfunction.
- History of obstructive sleep apnoea syndrome.
- History of any significant drug allergy including benzodiazepine.
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- A clinically significant history of drug or alcohol abuse.
- Inability to communicate well with the Investigator (i.e., language problem, poor mental development or impaired cerebral function).
- Participation in a clinical trial of a New Chemical Entity within the previous 3 months or of a Marketed Product within the previous 30 days (or 5 times the half-life, whichever is longer).
- Donation of 450 mL or more blood within the previous 3 months.
- Smoking or use of tobacco products or substitutes within the previous 6 months, as determined at the Screening visit.
- Need for administrative or legal supervision.
- Subject who would receive more than 4500 euros as indemnities for participation in biomedical research within 12 months, including the indemnities for the present study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label Study to Assess the Potential for Pre-systemic Inhibition of Cytochrome P450 3A4 (CYP3A) by Idebenone in Healthy Male Subjects Using Midazolam as a Substrate
This phase I open label study is conducted to assess the potential pharmacokinetic interaction of Raxone® with midazolam in healthy male volunteers
- Conditions
- Drug-Drug Interaction
- Being tested
- Raxone (idebenone 150 mg), Midazolam 2,5 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Raxone (idebenone 150 mg)Drug
Raxone (idebenone 300 mg t.i.d.) on days 3 and days 5 to 10
Midazolam 2,5 mgDrug
Midazolam (2,5 mg single oral dose) on days 1, 3 and 10
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve (AUC) from the time of dosing to the time of the last observed concentration (AUC0-t)
Measured: 13 days
Area Under the Curve (AUC) extrapolated to infinity from dosing time, based on the last observed concentration (AUC0-∞)
Measured: 13 days
Maximum plasma concentration (Cmax)
Measured: 13 days
Time to Maximum plasma concentration (Cmax) during a dosing interval (tmax)
Measured: 13 days
Terminal elimination half-life (t1/2)
Measured: 13 days
Clearance, calculated as dose/AUC0-∞ (CL/F)
Measured: 13 days
Volume of distribution during terminal phase after non-intravenous administration (Vz/F)
Measured: 13 days
Secondary outcomes (9)
Area Under the Curve (AUC) from the time of dosing to the time of the last observed concentration (AUC0-t)
Measured: 13 days
Area Under the Curve (AUC) extrapolated to infinity from dosing time, based on the last observed concentration (AUC0-∞)
Measured: 13 days
Maximum plasma concentration (Cmax)
Measured: 13 days
Time to Maximum plasma concentration (Cmax) during a dosing interval (tmax)
Measured: 13 days
Terminal elimination half-life (t1/2)
Measured: 13 days
Clearance (CL)
Measured: 13 days
Clearance, calculated as dose/AUC0-∞ (CL/F)
Measured: 13 days
Volume of distribution (Vz)
Measured: 13 days
Volume of distribution during terminal phase after non-intravenous administration (Vz/F)
Measured: 13 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug-Drug InteractionStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Santhera Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02887443
- Sponsor's protocol ID
- SNT-I-017
- Status last verified
- Oct 2017
- First submitted
- 3 Aug 2016
- Last updated
- 5 Oct 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Study to Assess the Potential for Pre-systemic Inhibition of Cytochrome P450 3A4 (CYP3A) by Idebenone in Healthy Male Subjects Using Midazolam as a Substrate
- ClinicalTrials.gov ID
- NCT02887443
- Acronym / sponsor ID
- SNT-I-017
- Conditions
- Drug-Drug Interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Santhera PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 2 Sep 2016 (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 phase I open label study is conducted to assess the potential pharmacokinetic interaction of Raxone® with midazolam in healthy male volunteers
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Healthy male aged 18 to 55 years.
- A Body Mass Index (BMI) of 18-30. BMI = Body weight (kg) / Height (m)2.
- Male subject willing to use an acceptable effective contraceptive measure for the entire duration of study participation.
- No clinically significant abnormal serum biochemistry, haematology and urine examination values.
- A negative urinary test for drugs of abuse and alcohol breath screen. A positive alcohol test may be repeated at the discretion of the Investigator.
Key exclusion criteria (13 listed)
- A clinically significant history of gastrointestinal disorder likely to influence drug absorption.
- Use of any medication (prescription or OTC, including health supplements and herbal remedies, except paracetamol, within 2 weeks or 5 half-lives (whichever is longer) prior to the first dose of trial medication.
- Use of any medication known to induce or inhibit any of the enzymes within the CYP3A system within 28 days of Day 1, or grapefruit within 7 days of Day 1
- Evidence of renal, hepatic dysfunction, cardiovascular or metabolic dysfunction.
- History of obstructive sleep apnoea syndrome.
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 |
|---|---|---|
| Raxone (idebenone 150 mg)Raxone (idebenone 300 mg t.i.d.) on days 3 and days 5 to 10 | Drug | – |
| Midazolam 2,5 mgMidazolam (2,5 mg single oral dose) on days 1, 3 and 10 | Drug | – |
Primary outcome
Area Under the Curve (AUC) from the time of dosing to the time of the last observed concentration (AUC0-t)
Time frame: 13 days
Area Under the Curve (AUC) extrapolated to infinity from dosing time, based on the last observed concentration (AUC0-∞)
Time frame: 13 days
Maximum plasma concentration (Cmax)
Time frame: 13 days
Time to Maximum plasma concentration (Cmax) during a dosing interval (tmax)
Time frame: 13 days
Terminal elimination half-life (t1/2)
Time frame: 13 days
Clearance, calculated as dose/AUC0-∞ (CL/F)
Time frame: 13 days
Volume of distribution during terminal phase after non-intravenous administration (Vz/F)
Time frame: 13 days
9 secondary outcomes
Area Under the Curve (AUC) from the time of dosing to the time of the last observed concentration (AUC0-t)
Time frame: 13 days
Area Under the Curve (AUC) extrapolated to infinity from dosing time, based on the last observed concentration (AUC0-∞)
Time frame: 13 days
Maximum plasma concentration (Cmax)
Time frame: 13 days
Time to Maximum plasma concentration (Cmax) during a dosing interval (tmax)
Time frame: 13 days
Terminal elimination half-life (t1/2)
Time frame: 13 days
Clearance (CL)
Time frame: 13 days
Clearance, calculated as dose/AUC0-∞ (CL/F)
Time frame: 13 days
Volume of distribution (Vz)
Time frame: 13 days
Volume of distribution during terminal phase after non-intravenous administration (Vz/F)
Time frame: 13 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 5 Oct 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Raxone (idebenone 150 mg) and Midazolam 2,5 mg in people with Drug-Drug Interaction, run by Santhera Pharmaceuticals at 1 site in France.
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 14 inclusion and 13 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 5 Oct 2017. 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 France. 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 Curve (AUC) from the time of dosing to the time of the last observed concentration (AUC0-t) (time frame: 13 days). The study lists 7 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 5 Oct 2017; AzTrials last refreshed its copy on 30 Oct 2026.