ADME Study of [14C]-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-centre, non-randomised study to evaluate the absorption, distribution, metabolism, and excretion (ADME) of an oral solution of [14C]-ibrexafungerp following administration in healthy male subjects. Each subject will receive a single dose of [14C]-ibrexafungerp and will be followed for up to 20 days. During this period total radioactivity will be measured in blood, urine and faeces.

Detailed Description
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This is a Phase 1, open-label, single-centre, non-randomised study to evaluate the absorption, distribution, metabolism, and excretion (ADME) of an oral solution of [14C]-ibrexafungerp following administration in healthy male subjects. Each subject will receive a single dose of [14C]-ibrexafungerp and will be followed for up to 20 days. During this period total radioactivity will be measured in blood, urine and faeces. All subjects will undergo preliminary screening procedures for the study at the screening visit. Subjects will be admitted to the clinical unit on the evening prior to dosing (Day -1). A single oral dose containing [14C]-ibrexafungerp oral solution will be administered to subjects. Individual subjects will be released from the clinical unit following study-related procedures on Days 8 to 20 according to their % of radioactivity collected in relation to the dose administered.

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 [14C]-Ibrexafungerp in Healthy Male Subjects

Conditions
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Fungal Infection

Intervention / Treatment
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* Drug: [14C]-Ibrexafungerp


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Healthy males Age 30 to 65 years of age at the time of signing informed consent Must be willing and able to participate in the whole study Must provide written informed consent Must agree to adhere to the contraception requirements Key Exclusion Criteria: Subjects who have received any investigational drug in a clinical research study within the 90 days prior to Day 1 Current smokers Recent radiation exposure Subjects who have been enrolled in a 14C ADME study in the last 12 months An acute or chronic disease determined by the investigator to be clinically significant Clinically significant abnormal clinical chemistry, haematology, coagulation or urinalysis at screening as judged by the investigator Evidence of renal impairment at screening History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder

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
Interventional Model Description: Open Label, single arm
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ibrexafungerp<br>Oral [14C]-Ibrexafungerp Single Dose | Drug: [14C]-Ibrexafungerp<br>* Radio-labeled Ibrexafungerp, single dose.<br>* Other names: [14C]-SCY-078;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mass balance | Amount recovered expressed as a percentage of the dose administered | Day 20 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Routes and rates of elimination of [14C]-ibrexafungerp | Metabolite concentrations in body fluids and excreta | Day 20 | 
| Number of subjects with treatment-emergent adverse events | Number of subjects with treatment-emergent adverse events | Day 20 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SCY-078, Ibrexafungerp, ADME