A Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics (PK) of Nemiralisib
Status:
Completed
Trial end date:
2018-03-12
Target enrollment:
Participant gender:
Summary
Nemiralisib is a potent anti-inflammatory agent for the treatment of chronic obstructive
pulmonary disease (COPD) and other inflammatory lung diseases. The Cytochrome P450 3A4
(CYP3A4) is a major route of clearance for nemiralisib. The co-administration of drug
therapies, which modulate CYP3A4, may alter the exposure of nemiralisib. Hence, this clinical
drug interaction study with itraconazole (a potent CYP3A4 inhibitor) is required. The study
will evaluate the PK, safety and tolerability of nemiralisib when administered alone and when
administered concomitantly with repeat doses of itraconazole in healthy males and females.
Subjects will receive treatment with nemiralisib alone in Period 1 and itraconazole followed
by nemiralisib in Period 2 in single sequence crossover manner. Approximately 20 subjects
will be enrolled such that approximately 16 evaluable subjects complete the study. Each
subject will participate in the study for approximately 7 weeks including screening visit, 2
treatment periods and a follow up visit.