A Phase 1, Open-Label, Drug-Drug Interaction Study Designed to Evaluate the Effect of Relacorilant on the Pharmacokinetics of the Sensitive P-gp Substrate Dabigatran Etexilate in Healthy Subjects
Summary & Conclusions
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- Following a single oral dose of 75 mg dabigatran etexilate, the free and total dabigatran plasma exposures (AUC0-inf) were similar in the absence and presence of 400 mg QD relacorilant
- There were small numeric increases in free and total dabigatran plasma Cmax in the presence of relacorilant compared to dabigatran alone; these increases are not considered to be clinically relevant
- Overall, 400 mg QD relacorilant had minimal-to-no impact on the free and total dabigatran plasma exposures, suggesting no dose adjustments are needed for P-gp substrates in the presence of relacorilant
- Dabigatran + relacorilant showed no change in TEAE profile when co-administered, compared with relacorilant administered alone