Oral Ibrexafungerp (SCY-078) vs Standard-of-Care Following IV Echinocandin in the Treatment of Invasive Candidiasis
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|ClinicalTrials.gov Identifier: NCT02244606|
Recruitment Status : Completed
First Posted : September 19, 2014
Last Update Posted : July 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Mycoses Candidiasis, Invasive Candidemia||Drug: SCY-078 Drug: Fluconazole Drug: Micafungin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open-Label, Randomized Study to Estimate Safety, PK, and Efficacy of Oral Ibrexafungerp (SCY-078) vs. Standard-of-Care Following IV Echinocandin Therapy in the Treatment of Invasive Candidiasis in Hospitalized Nonneutropenic Adults|
|Study Start Date :||September 2014|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||August 2016|
Experimental: SCY-078 500 mg
A single loading dose of SCY-078 1000-mg orally on the first day, followed by SCY-078 500-mg orally once-daily on subsequent days.
Experimental: SCY-078 750 mg
A single loading dose of SCY-078 1250-mg orally on the first day, followed by SCY-078 750-mg orally once-daily on subsequent days.
Active Comparator: Standard-of-care
Oral fluconazole 400 mg daily (with a loading dose of 800 mg on the first day) or IV micafungin 100 mg daily.
- Safety and tolerability, assessed by adverse events, clinical laboratory results, physical examination findings, ECG results, and vital sign measurements [ Time Frame: from time of informed consent through 6-weeks after last study drug ]
- Dose of SCY-078 that achieves the target exposure (AUC) [ Time Frame: during randomized study drug (administered for a maximum of 23 days) ]
- Global response [ Time Frame: end of all antifungal therapy (administered for a maximum of 28 days) ]
- Clinical response [ Time Frame: end of all antifungal therapy (administered for a maximum of 28 days) ]
- Microbiological response [ Time Frame: end of all antifungal therapy (administered for a maximum of 28 days) ]
- Relapse [ Time Frame: 2-weeks and 6-weeks after the end of all antifungal therapy ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02244606
|Study Director:||David Angulo, MD||Scynexis, Inc.|