A Study to Assess the Potential for Pre-systemic Inhibition of CYP3A by Idebenone Using Midazolam as a Substrate
Study Details
Study Description
Brief Summary
This phase I open label study is conducted to assess the potential pharmacokinetic interaction of Raxone® with midazolam in healthy male volunteers
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1 |
Study Design
Outcome Measures
Primary Outcome Measures
- Area Under the Curve (AUC) from the time of dosing to the time of the last observed concentration (AUC0-t) [13 days]
- Area Under the Curve (AUC) extrapolated to infinity from dosing time, based on the last observed concentration (AUC0-∞) [13 days]
- Maximum plasma concentration (Cmax) [13 days]
- Time to Maximum plasma concentration (Cmax) during a dosing interval (tmax) [13 days]
- Terminal elimination half-life (t1/2) [13 days]
- Clearance, calculated as dose/AUC0-∞ (CL/F) [13 days]
- Volume of distribution during terminal phase after non-intravenous administration (Vz/F) [13 days]
Secondary Outcome Measures
- Area Under the Curve (AUC) from the time of dosing to the time of the last observed concentration (AUC0-t) [13 days]
- Area Under the Curve (AUC) extrapolated to infinity from dosing time, based on the last observed concentration (AUC0-∞) [13 days]
- Maximum plasma concentration (Cmax) [13 days]
- Time to Maximum plasma concentration (Cmax) during a dosing interval (tmax) [13 days]
- Terminal elimination half-life (t1/2) [13 days]
- Clearance (CL) [13 days]
- Clearance, calculated as dose/AUC0-∞ (CL/F) [13 days]
- Volume of distribution (Vz) [13 days]
- Volume of distribution during terminal phase after non-intravenous administration (Vz/F) [13 days]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Healthy male aged 18 to 55 years.
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A Body Mass Index (BMI) of 18-30. BMI = Body weight (kg) / Height (m)2.
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Male subject willing to use an acceptable effective contraceptive measure for the entire duration of study participation.
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No clinically significant abnormal serum biochemistry, haematology and urine examination values.
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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.
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Negative HIV and Hepatitis B and C results.
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No clinically significant abnormalities in 12 lead electrocardiogram (ECG).
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No clinically significant abnormalities in blood pressure, pulse or oral temperature.
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No allergy or sensitivity to midazolam, idebenone or any of their excipients.
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No current or past medical condition that might significantly affect the pharmacokinetic or pharmacodynamic response to midazolam.
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Subject must be available to complete the study (including follow-up visit).
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Subject must satisfy a medical examiner about their fitness to participate in the study.
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Subject must provide written informed consent to participate in the study.
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Covered by Health Insurance System and/or in compliance with the recommendations of National Law in force relating to biomedical research.
Exclusion Criteria:
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A clinically significant history of gastrointestinal disorder likely to influence drug absorption.
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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.
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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
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Evidence of renal, hepatic dysfunction, cardiovascular or metabolic dysfunction.
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History of obstructive sleep apnoea syndrome.
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History of any significant drug allergy including benzodiazepine.
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A clinically significant history of drug or alcohol abuse.
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Inability to communicate well with the Investigator (i.e., language problem, poor mental development or impaired cerebral function).
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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).
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Donation of 450 mL or more blood within the previous 3 months.
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Smoking or use of tobacco products or substitutes within the previous 6 months, as determined at the Screening visit.
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Need for administrative or legal supervision.
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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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Eurofins Optimed | Gières | France | 38610 |
Sponsors and Collaborators
- Santhera Pharmaceuticals
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SNT-I-017