Evaluation of Vamorolone Mineralocorticoid Receptor Antagonism in Healthy Subjects

Inclusion Criteria

• Age of 18 to 55 years inclusive, at the time of signing the informed consent.
• Male 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
• Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

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, Intrauterine device (IUD), birth control pills taken by female partner, diaphragm with spermicide) 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.
• Subject is a non-smoker for at least 3 months prior to exposure to the study treatments.

Subjects 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 treatment.

• Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the Informed consent form (ICF) and in this protocol prior to any clinical study specific procedure.
• Supine systolic blood pressure of ≥ 90 mmHg and ≤ 140 mmHg, diastolic blood pressure of ≥ 50 mmHg and ≤ 90 mmHg, pulse rate of ≥ 45 bpm and ≤ 90 bpm, and tympanic body temperature of ≥ 35.0 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)
• 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 syndrome.
• An abnormal ECG, defined as:
• Pulse rate (PR) > 215 msec and 120 msec; QTcF > 440 msec by automated reading
• Any clinically significant cardiac conduction abnormalities
• Any atrial or ventricular arrhythmias
• 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)
• A past medical history of peptic ulcers, diverticulitis, and non-specific ulcerative colitis.
• History of complaints of frequent dizziness and /or vomiting spells or lightheadedness.
• 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.
• Known Gilbert's syndrome.
• 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).
• Known or suspected hypersensitivity or contraindications to the study treatments or any components of the formulation used, e.g., vamorolone, eple