Study to Evaluate the Pharmacokinetics of Single and Multiple Doses of Apremilast in Healthy Adult Male Korean Subjects
Condition: Pharmacokinetics
Intervention: Apremilast; Placebo
Intervention description: Tablet for oral administration; Tablet for oral administration
Intervention MeSH terms: Apremilast
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Part 1 of the study was a 3-treatment period, 3-sequence crossover study. Part 2 was a parallel-group, placebo-controlled, single-period study.
Masking: None (Open Label)
Masking description: Part 1 was a randomized open-label crossover study. Part 2 was a randomized, double-blind study.
Enrollment: 28.0
Sex: Male
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pharmacokinetics; Apremilast; Healthy Adult Male; Korean Subjects

Summary:

      This two-part study was designed to evaluate the pharmacokinetics (PK) of single and multiple
      doses of apremilast in healthy adult Korean males.
    

Eligibility criteria:

        Inclusion Criteria:

        - Subjects must satisfy the following criteria to be enrolled in the study:

          1. Healthy adult male Korean subjects between 18 and 45 years of age (inclusive) at the
             time of signing the informed consent form (ICF).

          2. Subject must understand and voluntarily sign an ICF prior to any study-related
             assessments/procedures being conducted.

          3. Subject is willing and able to adhere to the study visit schedule and other protocol
             requirements.

          4. Must be able to communicate with the Investigator and understand and comply with the
             requirements of the study.

          5. Must be in good health as determined by the Investigator according to past medical
             history, physical examination (PE), vital signs, 12-lead electrocardiogram (ECG), and
             laboratory tests.

          6. Must have a body mass index (BMI) between 18 and 30 kg/m^2 (inclusive).

          7. Clinical laboratory tests must be within normal limits or considered by the
             Investigator to be not clinically significant.

          8. Vital signs (systolic and diastolic blood pressure, pulse rate, and oral [or tympanic]
             body temperature) will be assessed in the supine position after the subject has rested
             for at least five minutes. Subject must be afebrile (febrile [oral or tympanic] is
             defined as ≥ 38°C or 100.3°F) with vital signs within the following ranges:

               -  Systolic blood pressure: 90 to 140 mm Hg;

               -  Diastolic blood pressure: 50 to 90 mm Hg;

               -  Pulse rate: 40 to 110 bpm.

          9. Must have a normal or clinically acceptable 12-lead ECG. Subjects must have a QTc
             value ≤ 450 msec.

         10. Must have a normal or clinically acceptable physical examination.

         11. Contraception Requirements:

             - Male subjects (including those who have had a vasectomy) who engage in activity in
             which conception is possible must use barrier contraception (latex or non-latex
             condoms NOT made out of natural [animal] membrane [for example, polyurethane]) while
             on Investigational Product (IP) and for at least 28 days after the last dose of
             investigational product (IP).

         12. 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 IP.

        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, psychiatric,
                  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.

               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.

               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 cholecystectomy 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 eight 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 hepatitis, or known to be a carrier of the hepatitis B surface
                  antigen (HBsAg), or hepatitis C virus (HCV) antibodies, or have a positive result
                  to the test for HBsAg, HCV antibodies or human immunodeficiency virus (HIV)
                  antibodies at Screening.