drugset
drugset / Trial / NCT07259330

To Determine the Effect of CYP Induction Following Administration of Nirogacestat in Healthy Adult Male Participants

NCT07259330 ↗

Phase 1 Completed 20 enrolled SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany
Non-randomizedCrossoverOpen-labelTreatment

Summary

This study will evaluate the effects of nirogacestat 100 mg twice daily (BID) on the pharmacokinetics (PK) of a cytochrome P450 (CYP) cocktail.

Timeline

Start
2025-10-27
Primary completion
2026-03-27
Completion
2026-03-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Bupropion Small molecule 20 mg Oral
Subject Flurbiprofen Small molecule 10 mg Oral
Subject Midazolam Small molecule 1 mg Oral
Comparator Nirogacestat Small molecule 100 mg Oral
Subject Omeprazole Other / unclassified 10 mg Oral
Subject Repaglinide Small molecule 0.05 mg Oral

Indications

No indication recorded.