Fungal Disease
Conditions
Brief summary
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.
Interventions
DRUGIbrexafungerp
carbon-14 (\[14\^C\])-Ibrexafungerp
Sponsors
Scynexis, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
30 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak Plasma Concentration (Cmax) of Ibrexafungerp | Day 1 and Day 4 | Peak Plasma Concentration (Cmax) of Ibrexafungerp will be estimated |
| Metabolite identification in plasma, urine and faeces | Day 26 | Determination of primary metabolites using liquid chromatography-radio-detection |
| Area under the plasma concentration versus time curve (AUC) of Ibrexafungerp | Day1 and Day 4 | Area under the plasma concentration versus time curve (AUC) will be estimated where possible |
| Area under the plasma concentration versus time curve (AUC) of total radioactivity | Day 1 and Day 4 | Area under the plasma concentration versus time curve (AUC) of total radioactivity in blood where possible |
| Mass balance recovery | Day 26 | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distribution of total radioactivity into blood cells | Day 4 | Evaluation of whole blood plasma concentration ratios for total radioactivity |
| Safety of Ibrexafungerp | Day 4 | Number of participants with treatment-related adverse events as assessed by the investigator. |
| Routes and rates of elimination of [14^C]-Ibrexafungerp | Day 26 | Determination of routes and rates of elimination of \[14C\]-Ibrexafungerp primarily by Ae total radioactivity for urine and faeces. |
Countries
United Kingdom
Outcome results
None listed