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Clinical trial

A Phase 1, Single-Sequence, Two-Period Crossover, Open-Label Study to Determine the Potential Induction Effect of Multiple 100 mg BID Oral Doses of Nirogacestat on a Cocktail of CYP Probe Substrates CYP2B6 (Bupropion), CYP2C8 (Repaglinide), CYP2C9 (Flurbiprofen), CYP2C19 (Omeprazole), and CYP3A4 (Midazolam) in Healthy Males

NCT07259330 is registered in ClinicalTrials.gov with SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
A Phase 1, Single-Sequence, Two-Period Crossover, Open-Label Study to Determine the Potential Induction Effect of Multiple 100 mg BID Oral Doses of Nirogacestat on a Cocktail of CYP Probe Substrates CYP2B6 (Bupropion), CYP2C8 (Repaglinide), CYP2C9 (Flurbiprofen), CYP2C19 (Omeprazole), and CYP3A4 (Midazolam) in Healthy Males
Lead sponsor
SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany
Phase
Phase 1
Overall status
Completed
Start date
October 27, 2025
Completion date
March 27, 2026
Enrollment
20 (actual)
Sites
1

Conditions

As the registry lists them; a condition with its own page is linked.

healthy