Study to Evaluate Bioavailability of Apremilast Oral Suspension Relative to Tablet and to Assess Effect of Food on the Pharmacokinetics (PK) of the Oral Suspension
Condition: Healthy Volunteers
Intervention: Apremilast Tablet; Apremilast Oral Suspension
Intervention description: 30 mg tablet; 30 mg oral suspension
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: 34.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Apremilast; Healthy volunteers; Bioavailability; Food effect; Pharmacokinetic

Summary:

      The purpose of this study is to assess how much of apremilast is found in the blood unchanged
      when administered as an oral suspension compared to when it is administered as a tablet
      formulation. The effect of food on apremilast oral suspension will also be evaluated. In
      addition, information on the safety and tolerability of apremilast will be obtained.
    

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 (ICF) 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 and female subjects of any race between 18 to 55 years of age (inclusive), and in
             good health as determined by the Investigator at the time of signing the informed
             consent document.

          4. Have a Body Mass Index (BMI) between 18 and 33 kg/m^2 (inclusive).

          5. No clinically significant laboratory test results as determined by the investigator.

          6. At the screening visit, must be afebrile, with supine systolic blood pressure (BP): 90
             to 140 mmHg, supine diastolic BP: 50 to 90 mmHg, and pulse rate: 40 to 110 bpm.
             Eligibility criteria for vital signs performed during check-in and/or predose on Day 1
             will be at the discretion of the Investigator.

          7. Must have a normal or clinically acceptable 12-lead electrocardiogram (ECG). Subjects
             must have a QTcF value ≤ 450 msec.

          8. Contraception Requirements:

               -  Must comply with the following acceptable forms of contraception. All female of
                  childbearing potential (FCBP) must use one of the approved contraceptive options
                  as described below while taking apremilast and for at least 28 days after
                  administration of the last dose of the apremilast.

               -  At the time of study entry, and at any time during the study when a FCBP's
                  contraceptive measures or ability to become pregnant changes, the Investigator
                  will educate the subject regarding contraception options and the correct and
                  consistent use of effective contraceptive methods in order to successfully
                  prevent pregnancy

             All FCBP must have a negative pregnancy test at Visits 1 and 2. All FCBP subjects who
             engage in activity in which conception is possible must use one of the approved
             contraceptive options described below:

             Option 1: Any one of the following highly effective methods: hormonal contraception
             (oral, injection, implant, transdermal patch, vaginal ring); intrauterine device
             (IUD); tubal ligation; or partner's vasectomy; OR Option 2: Male or female condom
             (latex condom or non-latex condom NOT made out of natural [animal] membrane [for
             example, polyurethane]); PLUS one of the following additional barrier methods: (a)
             diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive
             sponge with spermicide.

             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 IP.

          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
             investigational product.

         10. Subject is willing and able to adhere to the study visit schedule and other protocol
             requirements

        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,
             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.

          5. 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).

          6. Donated blood or plasma within 8 weeks before the first dose administration to a blood
             bank or blood donation center.

          7. 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.

          8. History of alcohol abuse (as defined by the current version of the DSM) within 2 years
             before dosing, or a positive alcohol screen.

          9. Known to have hepatitis, or known to be a carrier of the hepatitis B surface antigen
             (HBsAg), or hepatitis C antibody (HCV Ab), or have a positive result to the test for
             HBsAg, HCV Ab, or human immunodeficiency virus (HIV) antibodies at Screening.

             -