Study to Evaluate Pharmacokinetics of Prototype Modified-Release Formulations Of Apremilast in Healthy Men
Condition: Healthy Volunteers
Intervention: Apremilast Immediate Release; Apremilast Modified Release 1; Apremilast Modified Release 2; Apremilast Modified Release 3; Apremilast Modified Release 4; Apremilast Modified Release 5; Apremilast Modified Release 6; Apremilast Modified Release 8; Apremilast Modified Release 9; Apremilast Modified Release 11; Apremilast Modified Release 12; Apremilast Modified Release 13; Apremilast Modified Release 14
Intervention description: 30 mg immediate release tablets; 75 mg oral tablet of prototype modified release (MR) 1; 75 mg oral tablet of prototype MR 2; 75 mg oral capsule of prototype MR 3; 75 mg oral capsule of prototype MR 4; 75 mg oral capsule of prototype MR 5; 75 mg oral capsule of prototype MR 6; 80 mg oral capsule of prototype MR 8; 80 mg oral capsule of prototype MR 9; 80 mg oral capsule of prototype MR 11; 80 mg oral capsule of prototype MR 12; 80 mg oral capsule of prototype MR 13; 80 mg oral capsule of prototype MR 14
Intervention MeSH terms: Thalidomide; Apremilast
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 80.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Apremilast; Healthy male subjects; Pharmacokinetics

Summary:

      This study will assess up to 12 different oral formulations of apremilast to determine how
      much apremilast is absorbed by the body compared to a reference formulation.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects must satisfy ALL of the following criteria to be eligible for enrollment into the
        study:

          1. Must understand and voluntarily sign a written informed consent form prior to any
             study-related procedures being performed.

          2. Must be able to communicate with the investigator, understand and comply with the
             requirements of the study, and agree to adhere to restrictions and examination
             schedules.

          3. Male subjects of any race between 18 to 55 years of age (inclusive), and in good
             health as determined by the Investigator.

          4. Has a body mass index between 18 and 33 kg/m^2 (inclusive).

          5. No clinically significant laboratory tests as determined by the investigator.

          6. Must not have a fever, with systolic blood pressure: 90 to 140 mmHg and diastolic
             blood pressure: 60 to 90 mmHg, and pulse rate: 40 to 110 bpm (measurements taken while
             lying down).

          7. Must have a normal or clinically acceptable 12-lead electrocardiogram (ECG).

          8. Subjects (including those who have had a vasectomy) who engage in activity in which
             conception is possible must use barrier contraception (male latex condom or non-latex
             condom not made out of natural [animal] membrane [eg, polyurethane]) while on study
             medication, and for 28 days after the last dose of study medication.

          9. Must agree to refrain from donating sperm, blood or plasma (other than for this study)
             while participating in this study and for at least 28 days after the last dose of
             study drug.

        Exclusion Criteria:

        The presence of ANY of the following will exclude any healthy subject from enrollment into
        the study:

          1. History of any clinically significant and relevant neurological, gastrointestinal,
             renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine,
             hematological, allergic disease, drug allergies, or other major disorders.

          2. Any condition which places the subject at unacceptable risk if he were to participate
             in the study, or confounds the ability to interpret data from the study.

          3. Use of any prescribed systemic or topical medication within 30 days of the first dose
             administration, unless Sponsor agreement is obtained.

          4. Use of any non-prescribed systemic or topical medication (including vitamin/mineral
             supplements, and herbal medicines) within 14 days of the first dose administration,
             unless Sponsor agreement is obtained.

          5. Any surgical or medical condition possibly affecting drug absorption, distribution,
             metabolism and excretion, eg, bariatric procedure, colon resection, irritable bowel
             syndrome, Crohn's disease, etc. Subjects with cholecytectomy and appendectomy may be
             included.

          6. Exposure to an investigational drug (new chemical entity) within 30 days prior to the
             first dose administration or 5 half-lives of that investigational drug, if known
             (whichever is longer).

          7. Donated blood or plasma within 8 weeks before the first dose administration to a blood
             bank or blood donation center.

          8. History of drug abuse (as defined by the current version of the Diagnostic and
             Statistical Manual (DSM) within 2 years before dosing, or a positive drug screen
             reflecting consumption of illicit drugs.

          9. History of alcohol abuse (as defined by the current version of the DSM) within 2 years
             before dosing, or a positive alcohol screen.

         10. Known to have serum hepatitis, or known to be a carrier of the hepatitis B surface
             antigen (HBsAg), or hepatitis C virus (HCV) antibody, or have a positive result to the
             test for human immunodeficiency virus (HIV) antibodies at Screening.