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    Summary
    EudraCT Number:2024-000382-25
    Sponsor's Protocol Code Number:SCY-078-120
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2024-09-25
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2024-000382-25
    A.3Full title of the trial
    A Phase 1, Open-Label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Oral Ibrexafungerp (SCY-078) in Adolescent Female Subjects
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of Oral Ibrexafungerp (SCY-078) in Adolescent Female Subjects
    A.4.1Sponsor's protocol code numberSCY-078-120
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/164/2020
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSCYNEXIS, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSCYNEXIS, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSCYNEXIS, Inc.
    B.5.2Functional name of contact pointRegulatory Affairs
    B.5.3 Address:
    B.5.3.1Street Address1 Evertrust Plaza, 13th Floor
    B.5.3.2Town/ cityJersey City
    B.5.3.3Post code07302
    B.5.3.4CountryUnited States
    B.5.6E-mailinfo@scynexis.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameibrexafungerp citrate
    D.3.2Product code SCY-078
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIbrexafungerp citrate
    D.3.9.3Other descriptive nameIbrexafungerp citrate
    D.3.9.4EV Substance CodeSUB204225
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Vulvovaginal candidiasis
    E.1.1.1Medical condition in easily understood language
    Vaginal thrush
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10047784
    E.1.2Term Vulvovaginal candidiasis
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the plasma pharmacokinetics (PK) of ibrexafungerp in adolescent female subjects between 12 and 17 years old, after receiving one day of oral BID doses of ibrexafungerp.
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of ibrexafungerp in adolescent female subjects between 12 and 17 years old, after receiving one day of BID oral doses of ibrexafungerp.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Post-menarche female between 12 years to 17 years of age (ie, age 12 through 18 years minus 1 day) at the prestudy (screening and signing of informed consent/assent) visit.
    2. Body weight within normal age distribution and a body mass index (BMI) within the range of 14-25 kg/m2 for Cohort A and 15 to 28 kg/m2 for Cohort B inclusive, at Screening.
    3. Not pregnant confirmed by a negative urine pregnancy test (β-human chorionic gonadotropin [β-hCG]) at the site’s local laboratory, prior to enrollment in the study and must agree to use adequate double barrier birth control if sexually active.
    4. Willing and able to comply with all study procedures, including the confinement period, and study restrictions. Parent/guardian also agrees with all study procedures, including the confinement period, and study restrictions.
    5. Willing and able to sign and date written informed assent/consent and the parent/guardian is willing and able to sign and date written informed consent required by law.
    6. Normal hepatic and renal function, as assessed by the safety laboratory tests.
    7. In good health based on medical history, physical examination findings, vital sign measurements, 12-lead ECG results, and laboratory safety results.
    8. Nonsmoker and has not used nicotine or nicotine-containing products for at least 6 months prior to screening.
    E.4Principal exclusion criteria
    1. Pregnant or lactating.
    2. History of malignancy, with the exception of basal cell carcinoma.
    3. Current or recent (within 3 months) gastrointestinal (GI) disease (including irritable bowel disease) or any GI surgery (including gall bladder removal and gastric bypass) that could impact absorption of study drug, bile acid, or enterohepatic circulation.
    4. Unable to swallow tablet dosage forms (tablets were cut in half if needed).
    5. Any major surgery within 30 days of dosing with study drug.
    6. History of severe systemic organ disease (eg, kidney, liver, heart) including unexplained syncope, cardiac arrest, unexplained arrhythmia, or torsade de pointes.
    7. QTcF interval >480 at Screening or Day -1.
    8. Alcohol consumption within 48 hours before dosing or has a positive test result for drugs of abuse, alcohol, or cotinine at screening or before dosing.
    9. Consumption of more than 80 mg of caffeine in the past 24 hours prior to dosing.
    10. Other investigational therapy within the following time period prior to dose administration in the current study: 30 days or 5 half-lives or twice the duration of the biological effect of the investigational product (whichever was longer).
    11. History of an allergic reaction to ibrexafungerp or any of its excipients.
    12. Donated blood or plasma (>450 mL) or had significant blood loss within 30 days of dosing or received a blood transfusion within 30 days of dosing.
    13. themselves or guardian unwilling or unable to follow the procedures outlined in the protocol or other condition(s) that would prevent compliance with the study protocol, or in the opinion of the Investigator, the subject was not suitable for entry into the study.
    14. Evidence of chronic and/or acute or active liver disease as documented by medical history, physical examination, or diagnostic tests that are likely to affect the conduct of the trial or interpretation of the data.
    15. Significant uncontrolled disease that will complicate execution of the trial or interfere with the absorption, distribution, metabolism, or excretion of drugs via the gut.
    16. Hemoglobin value outside the normal range for females at screening.
    17. History of and/or current alcohol abuse (defined as consumption of more than 210 mL of alcohol per week; or the equivalent of fourteen 4-ounce glasses of wine, or fourteen 12-ounce cans/bottles of beer or wine coolers per week) or drug abuse or addiction within the last 2 years.
    E.5 End points
    E.5.1Primary end point(s)
    Plasma PK parameters of ibrexafungerp including maximum concentration (Cmax) following first and the second dose, area under the concentration-time curve (AUC0-12, AUC12-24, and AUC12-∞), time to maximum concentration (Tmax) after the first and the second dose, and elimination half-life (t½) after the second dose, after receiving one day of BID oral doses of ibrexafungerp.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Predose (0 hour), and at 1, 2, 4, 8, 12 (prior to the second dose), 13, 16, 24, 30, and 46 hours post first dose.
    E.5.2Secondary end point(s)
    Safety and tolerability as measured by adverse events, vital signs (blood pressure, heart rate, respiratory rate, and temperature), physical examination, 12-lead electrocardiogram (ECG), and laboratory safety (biochemistry, hematology, coagulation, and urinalysis), after receiving one day of BID oral doses of ibrexafungerp.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Adverse events: from screening to D30
    Vital signs: screening, predose, 2, 4, 13, 16, 24, 30h post first dose and D10
    Physical examination: screening, predose, 24h post firstdose and Day 10
    12 lead ECG: screening, 30h post first dose and D10
    Clinical laboratory tests: screening, 46h post first dose and D10
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Pharmacokinetics, safety, and tolerability in paediatric population (adolescent females)
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 Will this trial be conducted at a single site globally? Yes
    E.8.4 Will this trial be conducted at multiple sites globally? No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Mauritius
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Study completion is defined as the date the last subject completes the final visit in the study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial months2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 8
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 8
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 6
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: Mauritius
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