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

NCT07259330 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-05-01

No results posted yet for this study

Summary

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

Conditions

  • Healthy

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.

Sponsors & Collaborators

  • SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany

    lead INDUSTRY

Principal Investigators

  • Jeroen van de Wetering, MD · ICON plc

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07259330 on ClinicalTrials.gov