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

Exclusion Criteria

• •1\. 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 the 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.
• •2\. Participant has a history or presence of any condition possibly affecting drug absorption (e.g., gastrectomy).
• •3\. Participant has a medical history or abnormal findings at Screening or Day -4 that the investigator judges may put at risk achieving the objectives of the study or protecting the safety of the participant.
• •4\. Participant has an acute illness with symptoms 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.
• •5\. Participant has tested positive for hepatitis B virus, hepatitis C virus, or HIV, or has a clinically significant infection.
• •6\. Participant has blood pressure (BP) that is ≥140 mmHg systolic or ≥90 mmHg diastolic following at least 5 minutes of supine rest at Screening or Day -4. Additionally, BP that is \<90 mmHg systolic or \<45 mmHg diastolic following at least 5 minutes of a supine rest at Screening or Day -4.
• •7\. Participant has heart rate (HR) that is \<40 bpm or \>100 bpm after resting in a supine position for 5 minutes at Screening or Day -4.
• •8\. Participant has averaged QT interval corrected using Fridericia's formula results from valid triplicate ECGs \>450 msec at Screening or Day -4.
• •9\. Participant has family history of long QT syndrome, or of unexplained sudden death or drowning in a first-degree relative under age 50.
• •10\. Participant has an ECG waveform abnormality that interferes with QT/QTc interval measurement or interpretation. A participant with mild sinus arrhythmia or sparse isolated premature ventricular contractions is eligible at the investigator's discretion.
• •11\. Participant has a positive serum alcohol test or other drug screen test at Screening and/or Day -4.
• •12\. Participant has received any vaccine within 14 days prior to the first dose of study treatment administration on Day -3.
• •13\. Participant has received any CYP3A4 inhibitors or inducers within 21 days or 5 half-lives (whichever is longer) prior to Day -3.
• •14\. Participant has had concurrent use of, or has used any long-acting gastric acid reducing agents, including histamine-2 receptor antagonists and proton pump inhibitors, including over-the-counter agents, in the last 21 days prior to Day -3.
• •15\. Participant has received any prescription or nonprescription drugs (including vitamins and dietary or herbal supplements) within 3 weeks or 5 half-lives, if known (whichever is longer), prior to study treatment administration on Day -3, unless in the opinion of the investigator and sponsor that the medication will not interfere with the study.
• •16\. Participant has received an investigational product within 30 days or 5 times the half-lives, if known, of any drug used in the prior study (whichever is longer), or exposure to \>4 new investigational agents within 12 months prior to study treatment administration on Day -3.
• •17\. Participant has a known hypersensitivity or intolerance to any of the study treatments, or excipients thereof, or a history of drug or other allergy that, in the opinion of the investigator or sponsor medical monitor, contraindicates their participation.
• •18\. Participant has a history of excessive intake of alcohol, defined as an average an average weekly intake of \>21 units (1 unit is equivalent to 1 can or bottle \[250 mL\] of beer, or 1 measure \[35 mL\] of spirits, or 1 glass \[100 mL\] of wine) in the last 6 months prior to Screening.
• •19\. Participant has a history of illicit drug abuse within the past 2 years prior to Screening.
• •20\. Participant has consumed red wine or any fruit juices (including, but not limited to, grapefruit, grapefruit juice, pomelos, exotic citrus fruits, or grapefruit hybrids) within 72 hours of Day -4.
• •21\. Participant has used caffeine or other xanthine containing products (e.g., coffee, black tea, green tea, colas, cacao, guarana, guayusa, yerba mate) within 48 hours of Screening and Day -4.
• •22\. Participant regularly consumes excessive amounts (defined as \>5 cups per day) of caffeine, xanthine-containing products, or energy drinks, as judged by the investigator.
• •23\. Participant has used tobacco- or nicotine-containing products within 2 months prior to Screening.
• •24\. Participant has donated blood or had a loss of \>450 mL of blood within 60 days, or donation of plasma within 7 days prior to CRU admission on Day-4.
• •25\. Participant has received blood products within the 60 days prior to Screening.
• •26\. Participant is unwilling to avoid strenuous or unaccustomed activity, sunbathing, or contact sports within 96 hours prior to admission to the CRU and until discharge from the CRU.
• •27\. Participant is deemed unsuitable for this study in the opinion of the investigator for any additional reason, condition, or prior therapy.