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

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.

Timeline

Start

2012-02-01

Primary completion

2012-04-01

Completion

2012-04-01

Outcome

Mixed primary results

registry analysis (equivalence test); Apremilast Alone vs Apremilast + IV Rifampin; Ratio of Geometric Least Squares Means 96.35 (90% CI 88.56 to 104.82) NCT01561963 ↗

registry analysis (equivalence test); Apremilast Alone vs Apremilast + Multiple Dose Oral Rifampin; Ratio of Geometric Least Squares Means 27.88 (90% CI 25.63 to 30.34) NCT01561963 ↗

Publications

• Background Liu Y, Zhou S, Wan Y, Wu A, Palmisano M. The impact of co-administration of ketoconazole and rifampicin on the pharmacokinetics of apremilast in healthy volunteers. Br J Clin Pharmacol. 2014 Nov;78(5):1050-7. doi: 10.1111/bcp.12448.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Apremilast	Small molecule	30 mg	Oral
Subject	Rifampicin	Small molecule	600 mg	Oral

Indications

No indication recorded.