Comparing the Extent to Which Apremilast is Made Available in the Body After Administration as an Extended-release or Immediate-release Formulation

Korábbi kezelés

• History of suicidal ideation, suicide attempt, or major psychiatric illness within 6 months before informed consent.
• Malignancy within the previous 5 years, except for protocol-specified nonmelanoma skin cancers or cervical carcinoma in situ.
• Positive testing for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C, except for protocol-specified hepatitis B results consistent with prior vaccination or prior infection.
• Use of prohibited prescription or over-the-counter medications, herbal medicines, vitamins, or supplements within the protocol-specified period before study entry.
• Receipt of an investigational drug within 30 days or 5 half-lives, whichever is longer, before check-in.
• Previous participation in this study or another study investigating apremilast, or previous receipt of apremilast.
• Use of tobacco- or nicotine-containing products within 3 months before check-in.

Más betegség

• Clinically significant medical condition or disease that may pose a safety risk or interfere with study participation or interpretation of study results.
• Significant gastrointestinal disease, gastrointestinal surgery that could affect drug absorption, malabsorption syndrome, or inability to swallow oral medication.
• Known hypersensitivity, intolerance, or allergy to apremilast.
• History of alcohol or drug abuse within the protocol-specified periods, or positive alcohol or illicit drug testing.

Laborértékek

• Clinically significant cardiovascular disease or ECG abnormality, including clinically significant arrhythmia or prolonged QTcF(QT Interval Corrected for Heart Rate Using Fridericia's Formula).
• Clinically significant renal or hepatic impairment, including estimated glomerular filtration rate (eGFR) \<70 mL/min/1.73 m\^²(millilitres per minute per 1.73 square meters) or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>1.5 × the upper limit of normal.
• Recent blood, plasma, or platelet donation outside the protocol-specified limits.

Egyéb

• Poor peripheral venous access.
• Unable or unwilling to comply with protocol-required dietary, lifestyle, or other study restrictions.

• Healthy male or female participants, 18 to 60 years of age, inclusive.
• Body mass index (BMI) between 18.0 and 32.0 kg/m\^²(kilograms per meter square.), inclusive.
• In good health as determined by medical history, physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory evaluations.
• Female participants must not be pregnant or breastfeeding.
• Participants of reproductive potential must agree to follow protocol-specified contraception requirements.