Fungal Infection
Conditions
Keywords
SCY-078, Ibrexafungerp, ADME
Brief summary
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
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.
Interventions
DRUG[14C]-Ibrexafungerp
Radio-labeled Ibrexafungerp, single dose.
Sponsors
Inncelerex
Scynexis, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Open Label, single arm
Eligibility
Sex/Gender
MALE
Age
30 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mass balance | Day 20 | Amount recovered expressed as a percentage of the dose administered |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Routes and rates of elimination of [14C]-ibrexafungerp | Day 20 | Metabolite concentrations in body fluids and excreta |
| Number of subjects with treatment-emergent adverse events | Day 20 | Number of subjects with treatment-emergent adverse events |
Countries
United Kingdom
Outcome results
None listed