E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10047784 |
E.1.2 | Term | Vulvovaginal candidiasis |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main 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. |
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E.2.2 | Secondary 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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary 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. |
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E.5.1.1 | Timepoint(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. |
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E.5.2 | Secondary 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. |
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E.5.2.1 | Timepoint(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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
Pharmacokinetics, safety, and tolerability in paediatric population (adolescent females) |
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E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | 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.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
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E.8.7 | Trial 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
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Study completion is defined as the date the last subject completes the final visit in the study. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial months | 2 |