Conditions: Healthy Subjects
Keywords: Apremilast drug interaction pharmacokinetics
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 21
Healthy volunteers: yes

Brief summary:
The purpose of this study is to evaluate how the pharmacokinetics of apremilast may be affected by a single intravenous dose of rifampin and multiple oral doses of rifampin.

Detailed description:

Arms:
arm 1: Participants received the following 3 treatment regimens:

* A single oral dose of 30 mg apremilast on Day 1 (Period 1);
* A single oral dose of 30 mg apremilast followed 5 minutes later by a 30-minute intravenous infusion of 600 mg rifampin on Day 5 (Period 2);
* Once daily oral doses of 600 mg rifampin for 15 days (from Day 7 to Day 21) with a single oral dose of 30 mg apremilast co-administered with the rifampin dose on Day 20 (Period 3).

Interventions: intervention 1: Apremilast intervention 2: Rifampin Oral Capsules intervention 3: Rifampin IV Solution
Intervention descriptions: intervention 1: Tablets for oral administration intervention 2: Capsules for oral administration intervention 3: Intravenous (IV) solution

Protocol document: