Effect of Food on the Pharmacokinetics of Apremilast (CC-10004) in Healthy Adults

Amgen

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: Apremilast

Study type: Interventional

Funder types: Industry

Identifiers

NCT01634178

20200148 (Other Identifier)

CC-10004-CP-022

Details and patient eligibility

About

The purpose of the study is to evaluate the effects of a high fat meal on the pharmacokinetics of a single dose of 30 mg apremilast in healthy adults.

Full description

Participants will be randomized to receive a single dose of 30 mg apremilast during each of the 2 periods; once under fasting conditions and once after a high fat meal. Participants will be randomly assigned to receive apremilast either fasted first, then fed, or fed first then fasted. Participants will check into the study center on Day -1 of each period, will be dosed on Day 1, and discharged from the study center on Day 3 after all scheduled pharmacokinetic blood draws and safety evaluations. After a washout of 5 to 10 days, participants will return for period 2 during which they will receive apremilast according to their assigned sequence.

Enrollment: 46 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy male or female subjects of any ethnic origin between ages of 18 and 65 inclusive with a body mass index (BMI) between 18 and 33.

2. 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.

3. All other females must have been surgically sterilized at least 6 months prior to screening or be postmenopausal (to be confirmed by lab tests).

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

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Sequence 1: Apremilast Fasted / Fed

Experimental group

Description:

In Period 1 participants will receive a single 30 mg apremilast tablet administered under fasted conditions and in Period 2 participants will receive a single 30 mg apremilast tablet administered after a high fat meal.

Treatment:

Drug: Apremilast

Sequence 2: Apremilast Fed / Fasted

Experimental group

Description:

In Period 1 participants will receive a single 30 mg apremilast tablet administered after a high fat meal and in Period 2 participants will receive a single 30 mg apremilast tablet administered under fasted conditions.

Treatment:

Drug: Apremilast