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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single dose of [14^C]-Ibrexafungerp | Experimental | Each subject will receive a dose of [14C]-Ibrexafungerp at 12 h intervals for 7 doses in total. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibrexafungerp | Drug | carbon-14 ([14^C])-Ibrexafungerp |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Sciences Limited | Nottingham | United Kingdom |
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| ID | Term |
|---|---|
| D009181 | Mycoses |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C569338 | ibrexafungerp |
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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 |