A Clinical Study to Investigate the Effect of Gemfibrozil or Rifampicin on Blood Concentrations of Selexipag in Healthy Subjects

Phase 1 Completed 40 enrolled Actelion

RandomizedCrossoverOpen-labelOther

Summary

The primary objectives of this 2-part drug interaction study are as follows: * To evaluate the effect of gemfibrozil on the pharmacokinetics (i.e., amount in the blood) of selexipag and its metabolite ACT-333679 (Part I). * To evaluate the effect of rifampicin on the pharmacokinetics of selexipag and its metabolite ACT-333679 (Part II).

Timeline

Start: 2016-06
Primary completion: 2016-07
Completion: 2016-07

Publications

Bruderer S, Petersen-Sylla M, Boehler M, Remenova T, Halabi A, Dingemanse J. Effect of gemfibrozil and rifampicin on the pharmacokinetics of selexipag and its active metabolite in healthy subjects. Br J Clin Pharmacol. 2017 Dec;83(12):2778-2788. doi: 10.1111/bcp.13379. Epub 2017 Aug 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Gemfibrozil	Small molecule	600 mg	Oral
Subject	Rifampin	Small molecule	600 mg	Oral
Subject	Selexipag	Small molecule	400 ug	Oral

Indications

No indication recorded.