Effect of Multiple Doses of Modafinil on the Pharmacokinetics of Single Dose Lorlatinib in Healthy Participants
Status:
Completed
Trial end date:
2019-12-09
Target enrollment:
Participant gender:
Summary
The primary purpose of the study is to characterize the safety profile of lorlatinib in the
presence of a moderate CYP3A4/5 inducer, modafinil. In another drug-drug interaction study
for lorlatinib coadministered with a strong CYP3A4/5 inducer, rifampin, all participants
experienced increases in liver enzymes after receiving the combination of a single dose
lorlatinib (100 mg) with rifampin (600 mg daily (QD)) after multiple doses of rifampin. The
AST and ALT continued to increase over the next 24-48 hours, but recovered below the upper
limit of normal for all participants upon discontinuation of rifampin.
We hypothesize the combination of lorlatinib with the moderate CYP3A inducer modafinil will
not have a safety findings related to liver enzyme elevation similar to what occurred in the
study with rifampin and lorlatinib.