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

Completed · Phase 1

Conditions studied: Healthy Subjects

In brief

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.

Key facts

Study ID

NCT01561963

Run by

Amgen

People needed

21

Starts

2012-02-01

Expected to finish

2012-04-01

Last updated by the study team

2021-06-09

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Quintiles — Overland Park, Kansas, United States

Full record on ClinicalTrials.gov

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