Conditions: Pharmacokinetics
Keywords: Pharmacokinetics Apremilast Healthy Adult Male Korean Subjects
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 28
Healthy volunteers: yes

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

Detailed 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.

Arms:
arm 1: A single oral dose of 20 mg apremilast. arm 2: A single oral dose of 30 mg apremilast. arm 3: A single oral dose of 40 mg apremilast. arm 4: 30 mg apremilast orally twice a day (BID) for 14 days. arm 5: Matching placebo orally twice a day for 14 days.

Interventions: intervention 1: Apremilast intervention 2: Placebo
Intervention descriptions: intervention 1: Tablet for oral administration intervention 2: Tablet for oral administration

Protocol document: