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

This is a phase 1, open-label, randomized, three-period, six-sequence crossover study in
healthy subjects. The study will consist of a screening phase, a baseline phase, three study
periods, and a follow-up phone call. Each study period will be four days in duration (Day 1
through Day 4) of dosing followed by a five-day washout between doses.

Within no more than 21 days (Day -21) and no less than two days (Day -2) prior to the start
of the first study period, subjects will undergo routine screening procedures including a
12-lead electrocardiogram (ECG), vital signs, clinical laboratory safety tests, serology
screen, pregnancy and FSH testing, and drug/alcohol screen.

Eligible subjects will be admitted into the study center on Day -1 of study Period 1 for
baseline measurements. During each study period, subjects will receive a single 30 mg oral
dose of apremilast on Day 1 according to the assigned treatment sequence. Subjects will be
domiciled at the study center from Day 1 of study Period 1 through Day 4 of study Period 3,
including the 5 day washout between doses. All subjects will be discharged from the study
center on Day 4 of study Period 3 following completion of required study procedures.

A follow-up phone call will occur approximately four days (±2 days) after the discharge from
the study center.

The study will be conducted in compliance with International Conference on Harmonisation
(ICH) Good Clinical Practices (GCPs).

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.