Study to Evaluate the Pharmacokinetics of Single and Multiple Doses of Apremilast in Healthy Adult Male Korean Subjects

Amgen

Status and phase: Completed; Phase 1

Conditions: Pharmacokinetics

Treatments: Drug: Apremilast; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02802735

CC-10004-CP-033

Details and patient eligibility

About

This two-part study was designed to evaluate the pharmacokinetics (PK) of single and multiple doses of apremilast in healthy adult Korean males.

Full description

The study will consist of two parts. Part 1 will evaluate the PK of ascending single doses of apremilast. Part 2 will evaluate the PK of apremilast when administered as multiple doses over 14 days.

Enrollment: 28 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects must satisfy the following criteria to be enrolled in the study:

1. Healthy adult male Korean subjects between 18 and 45 years of age (inclusive) at the time of signing the informed consent form (ICF).

2. Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.

3. Subject is willing and able to adhere to the study visit schedule and other protocol requirements.

4. Must be able to communicate with the Investigator and understand and comply with the requirements of the study.

5. Must be in good health as determined by the Investigator according to past medical history, physical examination (PE), vital signs, 12-lead electrocardiogram (ECG), and laboratory tests.

6. Must have a body mass index (BMI) between 18 and 30 kg/m^2 (inclusive).

7. Clinical laboratory tests must be within normal limits or considered by the Investigator to be not clinically significant.

8. Vital signs (systolic and diastolic blood pressure, pulse rate, and oral [or tympanic] body temperature) will be assessed in the supine position after the subject has rested for at least five minutes. Subject must be afebrile (febrile [oral or tympanic] is defined as ≥ 38°C or 100.3°F) with vital signs within the following ranges:

   • Systolic blood pressure: 90 to 140 mm Hg;
   • Diastolic blood pressure: 50 to 90 mm Hg;
   • Pulse rate: 40 to 110 bpm.

9. Must have a normal or clinically acceptable 12-lead ECG. Subjects must have a QTc value ≤ 450 msec.

10. Must have a normal or clinically acceptable physical examination.

11. Contraception Requirements:

    • 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 Investigational Product (IP) and for at least 28 days after the last dose of investigational product (IP).

12. 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 IP.

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.
  5. 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.
  6. 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).
  7. Donated blood or plasma within eight weeks before the first dose administration to a blood bank or blood donation center.
  8. 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.
  9. History of alcohol abuse (as defined by the current version of the DSM) within 2 years before dosing, or a positive alcohol screen.
  10. Known to have hepatitis, or known to be a carrier of the hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies, or have a positive result to the test for HBsAg, HCV antibodies or human immunodeficiency virus (HIV) antibodies at Screening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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28 participants in 5 patient groups, including a placebo group

Part 1: Apremilast 20 mg

Experimental group

Description:

A single oral dose of 20 mg apremilast.

Treatment:

Drug: Apremilast

Part 1: Apremilast 30 mg

Experimental group

Description:

A single oral dose of 30 mg apremilast.

Treatment:

Drug: Apremilast

Part 1: Apremilast 40 mg

Experimental group

Description:

A single oral dose of 40 mg apremilast.

Treatment:

Drug: Apremilast

Part 2: Apremilast 30 mg BID

Experimental group

Description:

30 mg apremilast orally twice a day (BID) for 14 days.

Treatment:

Drug: Apremilast

Part 2: Placebo

Placebo Comparator group

Description:

Matching placebo orally twice a day for 14 days.

Treatment:

Drug: Placebo