A Clinical Study to Assess the Effect of Clopidogrel on the Pharmacokinetics of Selexipag and Its Active Metabolite in Healthy Male Subjects

Phase 1 Completed 22 enrolled Actelion

NaSingle-groupOpen-labelOther

Summary

The purpose of this study is to evaluate the effect of clopidogrel on the pharmacokinetics of selexipag and its active metabolite (ACT-333679) in healthy male adults (by determining the blood concentrations of selexipag and its metabolite). Also, the safety of selexipag when administered alone or with clopidogrel will be assessed.

Timeline

Start: 2018-03-05
Primary completion: 2018-05-10
Completion: 2018-05-18

Publications

Axelsen LN, Poggesi I, Rasschaert F, Perez Ruixo JJ, Bruderer S. Clopidogrel, a CYP2C8 inhibitor, causes a clinically relevant increase in the systemic exposure to the active metabolite of selexipag in healthy subjects. Br J Clin Pharmacol. 2021 Jan;87(1):119-128. doi: 10.1111/bcp.14365. Epub 2020 Jun 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Clopidogrel	Small molecule	75 mg	Oral
Subject	Selexipag	Small molecule	200 ug	Oral

Indications

No indication recorded.