A Drug-Drug Interaction Study to Evaluate the Effect of Rifampin on the Pharmacokinetics of Apremilast

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-01

Study Completion Date

2012-04-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Subjects

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Apremilast and Rifampin

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).

Group Type EXPERIMENTAL

Apremilast

Intervention Type DRUG

Tablets for oral administration

Rifampin Oral Capsules

Intervention Type DRUG

Capsules for oral administration

Rifampin IV Solution

Intervention Type DRUG

Intravenous (IV) solution

Interventions

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Apremilast

Tablets for oral administration

Intervention Type DRUG

Rifampin Oral Capsules

Capsules for oral administration

Intervention Type DRUG

Rifampin IV Solution

Intravenous (IV) solution

Intervention Type DRUG

Other Intervention Names

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CC-10004 Otezla® RIFADIN™ RIFADIN™

Eligibility Criteria

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Inclusion Criteria

* Healthy male or female subjects of any ethnic origin between ages of 18 and 55 with a body mass index between 18 and 33

Exclusion Criteria

* Recent history (i.e., within 3 years) of any clinically significant neurological, gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, endocrine, hematological, dermatological, psychological, allergic or other major disorders.
* Use of any prescribed or non-prescribed systemic or topical medication (including vitamins and herbal medicines, e.g. St. John's Wort) within 30 days of the first dose, unless an exception is granted by the sponsor.
* 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.
* Exposure to an investigational drug (new chemical entity) within 30 days prior to the first dose administration

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes