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

Phase 1CompletedNCT01561963

Amgen21 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Healthy Subjects

Interventions

ApremilastDRUG

Tablets for oral administration

Rifampin Oral CapsulesDRUG

Capsules for oral administration

Rifampin IV SolutionDRUG

Intravenous (IV) solution

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Quintiles

Overland Park, Kansas, United States

Outcomes

Primary Outcomes

Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUCt) of Apremilast