CTIS2023-503771-13-00RecruitingPhase 1
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of SPR001 (Tildacerfont)in Reducing Supraphysiologic Glucocorticoid Use in Adult Subjects with Classic Congenital Adrenal Hyperplasia - SPR001-204
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Spruce Biosciences Inc.
- Enrollment
- 90
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 65+ (—)
- Sex
- All
Inclusion Criteria
- •1.Male and female subjects =18 years old at screening., 2.Has a documented historical diagnosis of classic congenital adrenal hyperplasia due to 21-hydroxylase deficiency based on genetic mutation in CYP21A2 and/or elevated 17-hydroxyprogesterone and currently treated with hydrocortisone, hydrocortisone acetate, prednisone, prednisolone, methylprednisolone, dexamethasone., 3.Has lower limit of detection = androstenedione = 2.5x upper limit of normal at screening measured before an AM glucocorticoid dose., 4.Has been on a stable, supraphysiologic dose of glucocorticoid replacement for =1 month before screening., 5. For subjects with the salt-wasting form of congenital adrenal hyperplasia, subject has been on a stable dose of mineralocorticoid replacement for =1 months before screening., 6.Agrees to follow contraception guidelines . Male subjects must also agree to refrain from donating sperm throughout the Treatment Period and for 90 days after the last dose of study drug., 7.Is able to understand all study procedures and risks involved and provides written informed consent indicating willingness to comply with all aspects of the protocol.
Exclusion Criteria
- •1.Has a known or suspected diagnosis of any other known form of classic congenital adrenal hyperplasia (not due to 21-hydroxylase deficiency)., 12.a Rosiglitazone, aromatase inhibitors, testosterone, growth hormones, or any other medication or supplement that could impact subject safety or confound interpretation of study results., 12.b. The drugs listed in protocol., 13. Donation or receipt of blood from 90 days before Screening to the end of the study; donation or receipt of platelets, white blood cells, or plasma from 30 days before Screening to the end of the study., 3.Has a history of allergy or hypersensitivity to tildacerfont, any of its excipients, or any other CRF1 receptor antagonist, 4.Shows clinical signs or symptoms of adrenal insufficiency., 5.Has had a clinically significant unstable medical condition, medically significant illness, or chronic disease occurring within 30 days of screening., 6.Psychiatric conditions, including but not limited to bipolar disorder, schizophrenia, or schizoaffective disorders that are not effectively controlled on medication and may have an adverse impact on study compliance. Symptoms including hallucinations, delusions, and psychosis are exclusionary., 7.Has clinically significant abnormal ECG or clinical laboratory results., 8.Routinely works overnight shifts, 9.Subjects with travel plans/work schedules that result in significant and frequent changes in time zones (>2 hours) will require Medical Monitor approval for enrollment., 10.Females who are pregnant or nursing., 2.Has a history that includes bilateral adrenalectomy or hypopituitarism., 11.Use of any other investigational drug from 30 days or 5 half-lives (whichever is longer) before screening to the end of the study., 12.Use of the following drugs from 30 days or 5 half-lives (whichever is longer) before the start of the Glucocorticoid Conversion Period to the end of the study.
Investigators
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