Pharmacokinetics of Apremilast (CC-10004) in Healthy Elderly Subjects

This is an open-label, parallel group study where eligible elderly subjects (aged 65-85
years inclusive) and younger subjects (aged 18-55 years inclusive) and who are matched to
the elderly subjects by sex and BMI (± 10%) will receive a single dose of 30 mg apremilast
under fasting conditions. The subjects will check into the study center on Day -1, will be
dosed on Day 1, and discharged from the study center on Day 3 after all scheduled
pharmacokinetic blood draws and safety evaluations.

Inclusion Criteria:

Inclusion Criteria for elderly group

1. Healthy male or female subjects of any ethnic origin between ages of 65 and 85
inclusive with a body mass index (BMI) between 18 and 35.

2. Females must have been surgically sterilized at least 6 months prior to screening or
be postmenopausal (to be confirmed by lab tests).

3. Males must agree to use latex or polyurethane condoms when engaging in sex during the
study and for at least 28 days after dosing.

4. Elderly subjects with stable, chronic medical condition may be eligible if the
condition is well-controlled and medications do not interfere with study procedures
or pharmacokinetic interpretation

Inclusion Criteria for younger group:

1. Healthy male or female of any ethnic origin between the ages of 18 and 55 inclusive
with a BMI between 18 and 35.

2. Males must agree to use latex or polyurethane condoms when engaging in sex during the
study and for at least 28 days after dosing.

3. Females who are able to become pregnant have a negative pregnancy test at screening
and baseline, and must agree to use one of the following:

- a highly effective form of contraception (ex. Non-oral hormonal, intrauterine
device) OR

- oral hormonal contraceptive plus one additional form of barrier contraception OR

- two forms of barrier contraception These must be effective by the time of
screening. For younger females who are not able to become pregnant, the
conditions for the elderly females will apply.

Exclusion Criteria:

1. Any condition, including the presence of laboratory abnormalities, or psychiatric
illness, that would prevent the subject from signing the Informed Consent form,
places the subject at unacceptable risk if he were to participate in the study, or
confounds the ability to interpret data from the study.

2. Presence of any surgical or medical conditions possibly affecting drug absorption,
distribution, metabolism, and excretion, or plans to have elective or medical
procedures during the conduct of the trial.

3. 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).

4. Subjects with known serum hepatitis, is a known carrier of hepatitis B surface
antigen, hepatitis C antibody, or human immunodeficiency virus antibody.

5. Subjects who have used prescription systemic or topical medications within 30 days of
dosing, unless it is being used to treat a stable, chronic medical condition. This
includes medication that is an inhibitor or inducer of P-glycoprotein transporter and
CYP-3A4/5 used within 14 days of dosing.