Conditions: Healthy Volunteers
Keywords: Apremilast Healthy volunteers Bioavailability Food effect Pharmacokinetic
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 34
Healthy volunteers: yes

Brief summary:
The purpose of this study is to assess how much of apremilast is found in the blood unchanged when administered as an oral suspension compared to when it is administered as a tablet formulation. The effect of food on apremilast oral suspension will also be evaluated. In addition, information on the safety and tolerability of apremilast will be obtained.

Detailed description:
This is a phase 1, open-label, randomized, three-period, six-sequence crossover study in healthy subjects. The study will consist of a screening phase, baseline (Day -1), three study periods, and a follow-up phone call. Each study period will be four days in duration (Day 1 through Day 4) followed by a five-day washout between doses.

Eligible participants will be admitted into the study center on Day -1 of study Period 1 for baseline measurements. During each study period, participants will receive a single 30 mg oral dose of apremilast on Day 1 according to the assigned treatment sequence. Participants will be confined at the study center from Day 1 of study Period 1 through Day 4 of study Period 3, including the 5 day washout between doses. All participants will be discharged from the study center on Day 4 of study Period 3 following completion of required study procedures. A follow-up phone call will occur approximately four days after the discharge from the study center.

The study will be conducted in compliance with International Conference on Harmonisation (ICH) Good Clinical Practices (GCPs).

Arms:
arm 1: A single oral dose of 30 mg apremilast tablet after an overnight fast. arm 2: A single oral dose of 30 mg apremilast oral suspension formulation (6 mL) after an overnight fast. arm 3: A single oral dose of 30 mg apremilast oral suspension formulation (6 mL) after a high-fat meal.

Interventions: intervention 1: Apremilast Tablet intervention 2: Apremilast Oral Suspension
Intervention descriptions: intervention 1: 30 mg tablet intervention 2: 30 mg oral suspension

Protocol document: