Study to Evaluate the Safety and Efficacy of SPR001 in Subjects With Classic Congenital Adrenal Hyperplasia

Exclusion Criteria

• •Experienced a clinically significant AE considered at least possibly related to SPR001 in Study SPR001-201
• •If screening for this study occurs \>3 months after the subject's final follow-up visit in Study SPR001-201, the subject will be screened for any clinically significant unstable medical condition, medically significant illness, or chronic disease occurring within 30 days of screening
• •Is at increased risk of suicide
• •Clinically significant depression or anxiety at screening or baseline
• •Clinically significant abnormal clinical or laboratory assessments must be discussed with the Medical Monitor to determine eligibility for this study.
• •Subjects who routinely work overnight shifts require Medical Monitor approval for enrollment
• •Females who are pregnant or lactating
• •Use of any other investigational drug within 30 days or 5 half-lives before screening
• •Use of prohibited concomitant medications (including rosiglitazone, testosterone, and strong inhibitors and/or inducers of CYP3A4) within 30 days or 5 half-lives of baseline. Medications metabolized by CYP3A4, 2C8, 2C9, or 2C19, especially those that are sensitive substrates or substrates with narrow therapeutic ranges should be discussed on a case-by-case basis with the Medical Monitor.