ADME Study of [14^C]-Ibrexafungerp in Healthy Male Subjects

Study Overview
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Brief Summary
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This is a Phase 1, open-label, single center, non-randomized study to evaluate the absorption, distribution, metabolism and excretion (ADME) of an oral solution of radiolabeled Ibrexafungerp following repeat administration in healthy male subjects. All subjects will undergo preliminary screening procedures, will remain the clinical unit for approximately 26 days and will receive radiolabeled Ibrexafungerp, orally for 3 days.

Official Title
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A Phase 1, Open-Label, Single-Centre Study to Evaluate the Absorption, Distribution, Metabolism and Excretion (ADME) of Oral [14^C]-Ibrexafungerp in Healthy Male Subjects After Repeat Dosing

Conditions
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Fungal Disease

Intervention / Treatment
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* Drug: Ibrexafungerp


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy males aged 30 to 65 years willing and able to sign and informed consent. Exclusion Criteria: Clinically significant medical history or concurrent medical conditions included but not limited to infections, liver or kidney disease Use of certain concomitant medications History of smoking or alcohol abuse

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single dose of [14^C]-Ibrexafungerp<br>Each subject will receive a dose of [14C]-Ibrexafungerp at 12 h intervals for 7 doses in total. | Drug: Ibrexafungerp<br>* carbon-14 ([14^C])-Ibrexafungerp<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mass balance recovery | Mass balance recovery of total radioactivity in urine, faeces and all excreta (urine and faeces): cumulative recovery (CumAe) and cumulative recovery expressed as a percentage of the dose (Cum%Ae) | Day 26 | 
| Metabolite identification in plasma, urine and faeces | Determination of primary metabolites using liquid chromatography-radio-detection | Day 26 | 
| Area under the plasma concentration versus time curve (AUC) of Ibrexafungerp | Area under the plasma concentration versus time curve (AUC) will be estimated where possible | Day1 and Day 4 | 
| Area under the plasma concentration versus time curve (AUC) of total radioactivity | Area under the plasma concentration versus time curve (AUC) of total radioactivity in blood where possible | Day 1 and Day 4 | 
| Peak Plasma Concentration (Cmax) of Ibrexafungerp | Peak Plasma Concentration (Cmax) of Ibrexafungerp will be estimated | Day 1 and Day 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Routes and rates of elimination of [14^C]-Ibrexafungerp | Determination of routes and rates of elimination of [14C]-Ibrexafungerp primarily by Ae total radioactivity for urine and faeces. | Day 26 | 
| Distribution of total radioactivity into blood cells | Evaluation of whole blood plasma concentration ratios for total radioactivity | Day 4 | 
| Safety of Ibrexafungerp | Number of participants with treatment-related adverse events as assessed by the investigator. | Day 4 |