Evaluation of Vamorolone CYP3A4 Induction on Midazolam (a Sensitive CYP 3A4 Substrate) Pharmacokinetics

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.

Male subjects:

• If the subject is a sexually active man and not surgically sterilized, he must be willing to:
• Abstain from sexual intercourse or
• Use a condom plus another form of contraception, (e.g., spermicide, IUD, birth control pills taken by female partner) if engaging in sexual intercourse with a woman who could become pregnant.
• Use a condom during sexual intercourse with pregnant or lactating women.
• Must not father a child and must refrain from donating sperm from administration of the first dose and up to 3 months after the last dose of study treatment.

Female subjects:

All women (regardless of their status, i.e. WOCBP and WONCBP; for definitions see Section 10.4.1) must have a negative serum β-hCG pregnancy test prior to the initiation of the study treatments. FSH levels of suspected postmenopausal females must be > 30 mIU/mL.

Vamorolone has the potential to induce CYP3A4, which may result in a reduction in the effectiveness of contraceptives that are metabolized by CYP3A4 such as hormonal contraceptives when co-administered with vamorolone. Therefore, hormonal contraceptives by any route of administration are contraindicated.

Women participating in the study must be either:

• WONCBP or
• WOCBP using, during the length of the study and for at least 3 months after the stop of the study treatments, 1 of the following contraceptive methods plus a condom:
• IUD during the study and up to 3 months after the last administration of the study treatments
• Any IUD with published data showing that the lowest expected failure rate is less than 1% per year (not all IUDs meet this criteria)
• Any other methods with published data showing that the lowest expected failure rate for birth control is less than 1% per year, or
• Abstinent from intercourse for 2 weeks before exposure to the study treatments, throughout the clinical trial until 3 months following discontinuation of the study treatments, or
• Have a male partner who is sterile prior to the woman's entry into the study and is the sole sexual partner for that woman during the study period.

The Investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.

• 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).
• Subjects must be able to swallow the study treatments as per protocol.

Exclusion Criteria

• A past medical history of clinically significant abnormalities or a history/family history of long QT interval synd