Clinical trial: Study to Evaluate Bioavailability of Apremilast Oral Suspension Relative to Tablet and a Study to Assess Effect of Food on the Pharmacokinetic (PK) of the Oral Suspension (NCT02641353)

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 Boday Mass Index (BMI) between 18 and 33 kg/m2 (inclusive).

          5. No clinically significant laboratory test results as determined by the investigator.

          6. At the screening visit, must be afebrile, with supine systolic 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 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 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 HBsAg, or HCV Ab, or have a
             positive result to the test for HBsAg, HCV Ab, or HIV antibodies at Screening.

             -
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 55 Years

Patient description (medical language): A 19-year-old girl comes to the clinic due to a left wrist mass.  She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns.  Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms.

Patient description (patient's own words): I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms.

Does the patient match the trial criteria? Entailment