A Phase 2 interventional study of SCY-078 and Fluconazole in Mycoses, Candidiasis, Invasive and Candidemia, sponsored by Scynexis, Inc.. Completed at 30 sites in 5 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-06-25.
Sponsored by Scynexis, Inc. · Phase 2, Interventional, and Treatment
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.
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.
73 studies on the registry are indexed under Candidemia; 5 are open to participants now.
This study's enrollment of 27 is below the median of 63 across 44 interventional studies indexed under Candidemia.
Browse Candidemia studies →Scynexis, Inc. is the lead sponsor of 18 studies on the registry; none are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 10 (71%) have results posted.
Compared within Candidemia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Mycoses. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: SCY-078
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.
Drug: SCY-078
Oral fluconazole 400 mg daily (with a loading dose of 800 mg on the first day) or IV micafungin 100 mg daily.
Drug: Fluconazole · Drug: Micafungin
Safety and Tolerability, Assessed by Adverse Events, Clinical Laboratory Results, Physical Examination Findings, ECG Results, and Vital Sign Measurements
All Related TEAEs by SOC and PT, by Treatment, Safety
Time frame: up to 10 weeks
Dose of SCY-078 That Achieves the Target Exposure (AUC)
Summary of PK Parameters on Day 1 by Treatment Arm, from non-compartmental analysis, PK
Time frame: 0 to 24 hours post-dose
Global Response
Participant's clinical response (signs or symptoms) and microbiological response (presence of Candida culture)
Time frame: end of all antifungal therapy (administered for a maximum of 28 days)
Clinical Response
Participant's persistence of signs or symptoms and administration of systemic non-study antifungal therapy
Time frame: end of all antifungal therapy (administered for a maximum of 28 days)
Microbiological Response
Cultures or radiographs/imaging of blood or non-blood sites of infection showing evidence of Candida infection
Time frame: end of all antifungal therapy (administered for a maximum of 28 days)
Relapse
If Invasive Candida infection recurs or if antifungal therapy for a proven or suspected Candida infection is administered
Time frame: 2 weeks and 6 weeks after the end of all antifungal therapy, up to 10 weeks
| Milestone | Ibrexafungerp 500-mg | Ibrexafungerp 750-mg | Standard of Care (Fluconazole) | Standard of Care (Micafungin) |
|---|---|---|---|---|
| Started | 7 | 7 | 7 | 1 |
| Did not receive study drug | 1 | 0 | 0 | 0 |
| Did not complete randomized study drug | 1 | 1 | 2 | 0 |
| Completed | 4 | 2 | 4 | 0 |
| Not completed | 3 | 5 | 3 | 1 |
| Withdrew: Adverse event | 0 | 1 | 1 | 0 |
| Withdrew: Lost to follow-up | 2 | 2 | 1 | 0 |
| Withdrew: Protocol violation | 0 | 0 | 0 | 1 |
| Withdrew: Withdrawal by subject | 1 | 1 | 0 | 0 |
| Withdrew: Did not complete study for reason other: | 0 | 1 | 1 | 0 |
All Related TEAEs by SOC and PT, by Treatment, Safety
| Participants | Ibrexafungerp 500-mg | Ibrexafungerp 750-mg | Standard of Care (Fluconazole) | Standard of Care (Micafungin) |
|---|---|---|---|---|
| Patients with at least One Drug-Related TEAE | 1 | 1 | 0 | 0 |
| Patients with no Drug- Related TEAE | 5 | 6 | 7 | 1 |
Summary of PK Parameters on Day 1 by Treatment Arm, from non-compartmental analysis, PK
| Participants | Ibrexafungerp 500-mg | Ibrexafungerp 750-mg |
|---|---|---|
| Dose of SCY-078 That Achieves the Target Exposure (AUC) | 3 | 4 |
Participant's clinical response (signs or symptoms) and microbiological response (presence of Candida culture)
| Participants | Ibrexafungerp 500-mg | Ibrexafungerp 750-mg | Standard of Care (Fluconazole) | Standard of Care (Micafungin) |
|---|---|---|---|---|
| Favorable | 5 | 6 | 5 | 1 |
| Unfavorable | 2 | 1 | 2 | 0 |
Participant's persistence of signs or symptoms and administration of systemic non-study antifungal therapy
| Participants | Ibrexafungerp 500-mg | Ibrexafungerp 750-mg | Standard of Care (Fluconazole) | Standard of Care (Micafungin) |
|---|---|---|---|---|
| Favorable | 5 | 6 | 5 | 1 |
| Unfavorable | 1 | 0 | 2 | 0 |
| Unknown | 1 | 1 | 0 | 0 |
Cultures or radiographs/imaging of blood or non-blood sites of infection showing evidence of Candida infection
| Participants | Ibrexafungerp 500-mg | Ibrexafungerp 750-mg | Standard of Care (Fluconazole) | Standard of Care (Micafungin) |
|---|---|---|---|---|
| Favorable | 6 | 6 | 6 | 1 |
| Unfavorable | 0 | 0 | 1 | 0 |
| Unknown | 1 | 1 | 0 | 0 |
If Invasive Candida infection recurs or if antifungal therapy for a proven or suspected Candida infection is administered
| Participants | Ibrexafungerp 500-mg | Ibrexafungerp 750-mg | Standard of Care (Fluconazole) | Standard of Care (Micafungin) |
|---|---|---|---|---|
| Week 2 Post-Treatment — Relapsed | 1 | 0 | 0 | 0 |
| Week 2 Post-Treatment — Did Not Relapse | 4 | 4 | 5 | 0 |
| Week 2 Post-Treatment — Not Evaluable or Missing | 2 | 3 | 2 | 1 |
| Week 6 Post-Treatment — Relapsed | 0 | 0 | 0 | 0 |
| Week 6 Post-Treatment — Did Not Relapse | 4 | 2 | 4 | 0 |
| Week 6 Post-Treatment — Not Evaluable or Missing | 3 | 5 | 3 | 1 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ibrexafungerp 500-mg | 0/6 (0%) | 2/6 (33.3%) | 5/6 (83.3%) |
| Ibrexafungerp 750-mg | 1/7 (14.3%) | 4/7 (57.1%) | 4/7 (57.1%) |
| Standard of Care (Fluconazole) | 1/7 (14.3%) | 3/7 (42.9%) | 4/7 (57.1%) |
| Standard of Care (Micafungin) | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Event | Ibrexafungerp 500-mg | Ibrexafungerp 750-mg | Standard of Care (Fluconazole) | Standard of Care (Micafungin) |
|---|---|---|---|---|
| BacteremiaInfections and infestations | 1/6 | 0/7 | 0/7 | 0/1 |
| FungemiaInfections and infestations | 1/6 | 0/7 | 0/7 | 0/1 |
| Abdominal PainGastrointestinal disorders | 1/6 | 0/7 | 0/7 | 0/1 |
| Renal tubular necrosisRenal and urinary disorders | 1/6 | 0/7 | 0/7 | 0/1 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 1/6 | 0/7 | 0/7 | 0/1 |
| Abscess neckInfections and infestations | 0/6 | 1/7 | 0/7 | 0/1 |
| PyelonephritisInfections and infestations | 0/6 | 0/7 | 1/7 | 0/1 |
| Septic shockInfections and infestations | 0/6 | 0/7 | 1/7 | 0/1 |
| NauseaGastrointestinal disorders | 0/6 | 0/7 | 1/7 | 0/1 |
| VomitingGastrointestinal disorders | 0/6 | 0/7 | 1/7 | 0/1 |
| Event | Ibrexafungerp 500-mg | Ibrexafungerp 750-mg | Standard of Care (Fluconazole) | Standard of Care (Micafungin) |
|---|---|---|---|---|
| DiarrheaGastrointestinal disorders | 2/6 | 1/7 | 1/7 | 0/1 |
| Abdominal PainGastrointestinal disorders | 1/6 | 1/7 | 2/7 | 0/1 |
| NauseaGastrointestinal disorders | 0/6 | 2/7 | 1/7 | 0/1 |
| HeadacheNervous system disorders | 1/6 | 2/7 | 2/7 | 0/1 |
| HypokalemiaMetabolism and nutrition disorders | 0/6 | 2/7 | 0/7 | 0/1 |
| LeukocytosisBlood and lymphatic system disorders | 0/6 | 2/7 | 0/7 | 0/1 |
| PyrexiaGeneral disorders | 0/6 | 0/7 | 2/7 | 0/1 |
| VomitingGastrointestinal disorders | 1/6 | 1/7 | 1/7 | 0/1 |
| HyponatremiaMetabolism and nutrition disorders | 1/6 | 1/7 | 0/7 | 0/1 |
| DizzinessNervous system disorders | 0/6 | 1/7 | 1/7 | 0/1 |
| Age, Categorical(Participants) | Ibrexafungerp 500-mg | Ibrexafungerp 750-mg | Standard of Care (Fluconazole) | Standard of Care (Micafungin) | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 6 | 6 | 6 | 1 | 19 |
| >=65 years | 1 | 1 | 1 | 0 | 3 |
| Age, Continuous(years) | Ibrexafungerp 500-mg | Ibrexafungerp 750-mg | Standard of Care (Fluconazole) | Standard of Care (Micafungin) | Total |
|---|---|---|---|---|---|
| Mean | 56.4 ± 7.81 | 48.9 ± 15.46 | 49.6 ± 15.66 | 63.0 ± NA | 52.1 ± 13.17 |
| Sex: Female, Male(Participants) | Ibrexafungerp 500-mg | Ibrexafungerp 750-mg | Standard of Care (Fluconazole) | Standard of Care (Micafungin) | Total |
|---|---|---|---|---|---|
| Female | 2 | 4 | 5 | 0 | 11 |
| Male | 5 | 3 | 2 | 1 | 11 |
| Ethnicity (NIH/OMB)(Participants) | Ibrexafungerp 500-mg | Ibrexafungerp 750-mg | Standard of Care (Fluconazole) | Standard of Care (Micafungin) | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 2 | 0 | 1 | 0 | 3 |
| Not Hispanic or Latino | 5 | 7 | 6 | 1 | 19 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Ibrexafungerp 500-mg | Ibrexafungerp 750-mg | Standard of Care (Fluconazole) | Standard of Care (Micafungin) | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 1 | 0 | 3 |
| White | 4 | 6 | 6 | 1 | 17 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 0 | 0 | 0 | 2 |
| Region of Enrollment(participants) | Ibrexafungerp 500-mg | Ibrexafungerp 750-mg | Standard of Care (Fluconazole) | Standard of Care (Micafungin) | Total |
|---|---|---|---|---|---|
| United States | 7 | 7 | 7 | 1 | 22 |
The record gives a start of Sep 2014, a primary completion of Jun 2016 and a completion of Aug 2016. It does not say whether these dates are actual or estimated.
Results were first posted in Jun 2024, 8 years after primary completion. A results delay was requested in Oct 2020.
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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ibrexafungerp
Scynexis, Inc.