Open-Label Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Oral Ibrexafungerp (SCY-078) as an Emergency Use Treatment for Patients With Candidiasis, Including Candidemia, Caused by Candida Auris

SCY-078-305

This is a multicenter, open-label, non-comparator, single-arm study to evaluate the efficacy, safety, tolerability and PK (pharmacokinetics) of oral SCY-078 as an emergency use treatment for patients with a documented Candida auris infection.

2017-11-15

2023-04-14

2023-05-24

Completed

Early phase I

30

Inclusion Criteria: * Subject must fulfill the following KEY criteria to be eligible for study admission: 1. Subject is a male or female adult ≥ 18 years of age on the day the study informed consent form (ICF) is signed. 2. Subject has a documented candidiasis, including candidemia, caused by Candida auris. The subject is also eligible if he/she is receiving IV antifungal therapy for their C. auris infection and, in the judgment of the investigator, long-term IV antifungal therapy is not feasible or desirable due to clinical or logistical circumstances. A documented candidiasis, including candidemia, caused by Candida auris is defined as the recovery of Candida auris by culture of a sample obtained within the last 7 days. 3. Subject is able to tolerate medication orally or through a nasogastric (NG) tube or percutaneous endoscopic gastrostomy (PEG) tube. Exclusion Criteria: * KEY exclusion criteria: 1. Subject has a fungal disease with central nervous system involvement. 2. Subject has a fungal disease of the bone and/or joint that is expected to require \>90 days of study drug treatment. 3. Subject has an inappropriately controlled fungal infection source (e.g., persistent catheters, devices, identified abscess) that is likely the source of the fungal infection. 4. Subject is hemodynamically unstable and/or requiring vasopressor medication for blood pressure support. 5. Subject has abnormal liver test parameters: AST or ALT \>10 x ULN, and/or total bilirubin \>5 x ULN. Note: Subjects with unconjugated hyperbilirubinemia with diagnosis of Gilbert's disease are not excluded. 6. Subject has an Apache score \>16. 7. Subject has serum creatinine \>3 times from Baseline (Screening/Treatment Day 1) value.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'non comparator, single arm', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ACTUAL'}}

2023-06-27