CompletedPhase 1

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

Netherlands20 participantsStarted 2025-10-27

Plain-language summary

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

Who can participate

Age range

18 Years – 55 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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 prior to any study-related procedures being performed.
. Participant is a male between 18 and 55 years of age (inclusive) at the time of informed consent.
. Participant has a body mass index (BMI) ≥18 kg/m2 and ≤32 kg/m2 (inclusive) at Screening and Day -4, and a total body weight \>50 kg.
. 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 electrocardiogram \[ECG\] and the results of clinical chemistry coagulation and urinalysis carried out at Screening and Day -4.
. Participant has alanine aminotransferase, aspartate aminotransferase, and total bilirubin levels less than 1.5×the upper limit of normal at Screening and at Day -4.
. Participant has a renal function (creatinine clearance ≥90 mL/min), as evidenced by normal estimated glomerular filtration rate measured by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation at Screening and at Day -4.
. Participants that agree to the following during the Treatment Period, and for at least 7 days after the last dose of study treatment:
. Refrain from donating or preserving sperm; PLUS either

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Plasma area under the concentration-time curve from dosing extrapolated to infinity (AUCinf) and maximum observed plasma concentration (Cmax) for the CYP cocktail probes alone, and coadministered with nirogacestat.

Timeframe: CYP cocktail - Day -3 and Day 15 at predose (-60 minutes) and at 0.5, 1, 2, 3, 4, 6, 8, (10% nominal), 12, 24, 48, and 72 hours and nirogacestat Days 1 through 17 predose trough samples should be obtained within 1 hour of the nominal time from dosing.

Maximum Observed Plasma Concentration (Cmax) of the CYP cocktail probes alone, and coadministered with nirogacestat.

Trial details

NCT IDNCT07259330

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

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-03-27

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