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Recruiting Phase 1 NCT07171619

Evaluate the Effects of Famotidine or Rabeprazole on the PK of Nirogacestat

Trial Parameters

Condition Healthy
Sponsor SpringWorks Therapeutics, Inc.
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 24
Sex MALE
Min Age 18 Years
Max Age 55 Years
Start Date 2025-09-09
Completion 2025-11
Interventions
NirogacestatNirogacestat and FamotidineNirogacestat and Rabeprazole

Brief Summary

This study will evaluate the effects of the H2 blocker famotidine or the PPI rabeprazole on the PK of nirogacestat in healthy male participants

Eligibility Criteria

Inclusion Criteria: 1. Participant understands the study procedures, is willing to comply with all study requirements and restrictions, and agrees to participate in the study by providing written informed consent as described in Appendix 1 of the protocol, prior to any study-related procedures being performed. 2. Participant is a male (assigned at birth) between 18 and 55 years of age (inclusive) at the time of informed consent. 3. Participant has a body mass index (BMI) ≥18.0 kg/m2 and ≤32.0 kg/m2 (inclusive) at Screening and a total body weight \>50 kg. 4. Participant is considered to be medically healthy, as determined by a responsible and experienced investigator, based on a clinical evaluation (including medical history, physical examination, clinical laboratory tests, vital sign measurements, and a 12-lead ECG performed, and the results of clinical chemistry, hematology, coagulation, and urinalysis carried out at Screening and Day -1. 5. Participant has alanine aminotransferase (

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