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ACTIVE NOT RECRUITING
NCT07259330
PHASE1

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

Sponsor: SpringWorks Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

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

Official 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

Key Details

Gender

MALE

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2025-10-27

Completion Date

2026-03-29

Last Updated

2026-04-01

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

Nirogacestat

100 mg tablet Day 1 through Day 17

DRUG

Nirogacestat and Cocktail of CYP Specific Probe Substrates

Drug: Nirogacestat 100 mg tablet Day 1 through Day 17 and Drug: Cocktail of CYP Specific Probe Substrates administered Day 15.

Locations (1)

ICON Martini Groningen CRU

Groningen, Netherlands