Effects of Age and Sex on the Pharmacokinetics of Apremilast in Healthy Adults
Condition: Healthy Volunteer
Intervention: Apremilast
Intervention description: One oral 30 mg dose of apremilast
Intervention MeSH terms: Apremilast
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Apremilast; pharmacokinetic; safety; Pharmacokinetics and safety in healthy volunteer subjects

Summary:

      The purpose of the study is to evaluate the effects of age and sex on the pharmacokinetics
      and safety of a single oral dose of 30 mg apremilast in healthy adults.
    

Eligibility criteria:

        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.