To Determine the Effect of CYP Induction Following Administration of Nirogacestat in Healthy Adult Male Participants
Trial Parameters
Brief Summary
This study will evaluate the effects of nirogacestat 100 mg twice daily (BID) on the pharmacokinetics (PK) of a cytochrome P450 (CYP) cocktail.
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 prior to any study-related procedures being performed. 2. Participant is a male between 18 and 55 years of age (inclusive) at the time of informed consent. 3. 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. 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 electrocardiogram \[ECG\] and the results of clinical chemistry coagulation and urinalysis carried out at Screening and Day -4. 5. Participant has alanine aminotransferase, aspartate aminotransferase, and total bilirubin levels less