A Randomized, Double Blind, Placebo Controlled, Dose-Ranging Study to Evaluate The Efficacy and Safety of SPR001 (Tildacerfont) in Adult Subjects with Classic Congenital Adrenal Hyperplasia
To evaluate the effect of tildacerfont in reducing A4 (androstenedione) in subjects with CAH (Congenital Adrenal Hyperplasia) over 12 weeks.
Participants will be asked to complete 15 study visits (done in-clinic or via telemedicine) and at least 4 telephone contacts. Some study visits require fasting (no food after midnight and nothing to drink except water after 8 pm). During the study visits, participants will provide information regarding their health and medications, and undergo a physical exam. Fasting blood and urine samples will be collected during the visits and participants will have an electrocardiogram (ECG). Participants will be required to do the following: • Give correct and accurate information about your medical history, medication list, and current medical condition • Take their glucocorticoids and study drug dose as instructed by study doctor and record everything in their electronic diary (eDiary) • Carry their Patient Emergency Card with them at all times while participating in this study • Talk to the study doctor before taking any new medication during the study. • Complete their acne assessments every 4 weeks in your eDiary • Female participants may be required to enter menstrual information and complete the assessment of unwanted, male-pattern hair growth every 4 weeks in your eDiary • Male participants may be required to have a scrotal ultrasound • Tell the study doctor about any side effects or problems that you experience during the study • Follow birth control requirements • Do not eat grapefruit or drink grapefruit juice during your participation in the study • Do not participate in heavy exercise for 8 hours before any visit where blood samples will be drawn and in any type of exercise within 30 minutes before any study procedure
Age 18 years or older
Have classic congenital adrenal hyperplasia (CAH)