CompletedPhase 1

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

United States24 participantsStarted 2025-08-21

Plain-language 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

Who can participate

Age range18 Years – 55 Years

SexMALE

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 as described in Appendix 1 of the protocol, prior to any study-related procedures being performed.
✓. Participant is a male (assigned at birth) between 18 and 55 years of age (inclusive) at the time of informed consent.
✓. 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.
✓. 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.
✓. Participant has alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin levels \<1.5 × the upper limit of normal (ULN) at Screening and at Day -1.
✓. Participant has normal renal function (creatinine clearance ≥90 mL/min) as evidenced by normal estimated glomerular filtration rate (eGFR) measured by the CKD-EPI equation.
✓. Participant agrees to the following during the treatment periods and for at least 7 days after the last dose of study treatment:
✓. Refrain from donating or preserving sperm; PLUS either

Exclusion criteria

✕. Participant has a history or presence of oncologic, cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, ocular, endocrine, immunologic, dermatologic, musculoskeletal, neurologic, psychiatric, or other disease or condition or laboratory test abnormality that in the investigator's judgment poses a significant risk to the safety of the participant or the achievement of study objectives.
✕. Participant has a history or presence of any condition possibly affecting drug absorption (e.g., gastrectomy).
✕. Participant has a medical history or abnormal findings at Screening or Day -1 that the investigator judges may put at risk achieving the objectives of the study or protecting the safety of the participant.
✕. Participant has an acute illness with symptom or treatment that has started or persisted within 14 days prior to study treatment administration unless mild in severity and enrollment is approved by both investigator and sponsor's medical monitor.
✕. Participant has tested positive for active Helicobacter pylori (H. pylori) infection.
✕. Participant has tested positive for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) or has a clinically significant infection.
✕. Participant has blood pressure (BP) that is ≥140 mmHg systolic or 90 mmHg diastolic following at least 5 minutes of rest in the supine position at Screening and Day -1. Additionally, BP that is \<90 mmHg systolic or 45 mmHg diastolic following at least 5 minutes of rest at Screening and Day -1.
✕. Participant has heart rate (HR) that is \<40 bpm or \>100 bpm after resting in a supine position for 5 minutes at Screening and Day -1.

What they're measuring

Area under the concentration-time curve from time zero to infinity of nirogacestat.

Timeframe: Serial blood samples will be collected to determine concentrations of nirogacestat (in serum) on Day 1, Day 6, and Day 17 predose (-30 minutes) and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, and 96 hours postdose

Maximum serum concentration (Cmax) of nirogacestat.

Effect of a single 2-hour staggered dose of famotidine on the PK AUCinf of nirogacestat

Effect of a single 2-hour staggered dose of famotidine on the PK Cmax of nirogacestat

Trial details

NCT IDNCT07171619

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

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-11-10

View on ClinicalTrials.gov More Healthy trials