Evaluation of Vamorolone CYP3A4 Induction on Midazolam (a Sensitive CYP 3A4 Substrate) Pharmacoki… (NCT06689527) | Clinical Trial Compass
CompletedPhase 1
Evaluation of Vamorolone CYP3A4 Induction on Midazolam (a Sensitive CYP 3A4 Substrate) Pharmacokinetics
Germany18 participantsStarted 2024-08-13
Plain-language summary
The purpose of this study was to investigate how vamorolone affects the CYP3A4 enzyme in humans by measuring the pharmacokinetics of midazolam and its metabolite, 1'-hydroxymidazolam, in healthy subjects. The pharmacokinetics of midazolam were measured on Day 1 and then on Day 14 to investigate the potential interaction between the two compounds.
The safety and the tolerability was also investigated.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. Age of 18 to 55 years inclusive, at the time of signing the informed consent.
✓. Subject is overtly healthy as determined by medical evaluation including medical history, physical examination, vital signs, laboratory tests, and ECG.
✓. Body weight ≥ 50 kg and a BMI ≥ 18 kg/m2 and ≤ 29.9 kg/m2 at screening.
✓. Male and female. Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
✓. Subject is a non-smoker for at least 3 months prior exposure to the study treatments. Subject must also have abstained from use of other nicotine containing products (e.g., nicotine patch, chewing gum or e-cigarettes) for at least 3 months before exposure to the study treatments.
✓. Capable of giving signed informed consent as described in Section 10.1, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol prior to any clinical study specific procedure.
✓. Supine systolic blood pressure ≥ 90 mmHg and ≤ 140 mmHg; diastolic blood pressure ≥ 50 mmHg and ≤ 90 mmHg and pulse rate ≥ 45 bpm and ≤ 90 bpm, and tympanic body temperature ≥ 35.0 °C and ≤ 37.5 °C at screening.
✓. Subjects must be able to communicate well with the Investigator and comply with the protocol requirements, instructions, and protocol related restrictions (e.g. dietary, fluid and lifestyle restrictions from screening to study completion; Section 5.3).
Exclusion criteria
✕0. A past medical history of clinically significant abnormalities or a history/family history of long QT interval syndrome, structural cardiac abnormalities (including but not limited to hypertrophic cardiomyopathy, valvulopathy, and congenital defects), or cardiogenic syncope.
✕2. A past medical history of myocardial infarction, angina pectoris, atherosclerosis or other clinically significant heart disease (e.g., congestive heart failure, uncontrolled hypertension, history of labile hypertension).
✕3. A past medical history of peptic ulcers, diverticulitis, and non-specific ulcerative colitis.
✕4. History of complaints of frequent dizziness and /or vomiting spells or lightheadedness ("frequent" defined as incidence occurs more than once every week) or history of/or present sleep apnea.
✕5. Any history or evidence of any clinically relevant, gastrointestinal, respiratory, hepatic, renal, endocrinologic, hematologic, immunologic, metabolic, genitourinary, pulmonary, neurologic, dermatologic, musculoskeletal, and/or other major disease or malignancy as determined by medical evaluation (including physical examination) capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study treatments; or interfering with the interpretation of data.
✕6. Known Gilbert's syndrome.
✕7. Any clinically relevant history of allergic conditions requiring hospitalization or prolonged systemic treatment (including drug allergies, allergic asthma, eczema, allergies requiring therapy with corticosteroids or anaphylactic reactions); but excluding untreated, asymptomatic, seasonal allergies at time of dosing or allergic contact sensitizations (e.g., nickel allergy).