Oral Ibrexafungerp (SCY-078) vs Standard-of-Care Following IV Echinocandin in the Treatment of Invasive Candidiasis

Overview

The purpose of this study is to compare the safety, pharmacokinetics, and efficacy of oral SCY-078 vs. standard-of-care following initial intravenous echinocandin therapy in the treatment of invasive candidiasis.

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2016

Detailed Description

Patients will receive initial intravenous (IV) echinocandin therapy. Patients who are eligible for randomization will receive SCY-078 500-mg orally, SCY-078 750-mg orally, or standard-of-care.

Interventions

  • Drug: SCY-078
  • Drug: Fluconazole
  • Drug: Micafungin

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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)

Secondary Measures

  • 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

Participating in This Clinical Trial

Inclusion Criteria

  • Diagnosis of invasive candidiasis defined as a positive culture of blood or from another normally sterile site for Candida. – Not of reproductive potential or if of reproductive potential, agrees to remain abstinent or use 2 methods of contraception. Exclusion Criteria:

  • Patient with Candida endocarditis, osteomyelitis, meningitis, or chronic disseminated candidiasis or evidence of endophthalmitis. – Patient has failed treatment with an echinocandin for this episode of invasive candidiasis. – Infection limited to the oropharynx, esophagus, urogenital system, or skin, or sputum/bronchoalveolar lavage culture. – Participation in a clinical study with other investigational drug(s) within 30 days prior to study entry or during this study.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Scynexis, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • David Angulo, MD, Study Director, Scynexis, Inc.

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