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
Overview
- Phase
- Phase 1
- Intervention
- Ibrexafungerp
- Conditions
- Fungal Disease
- Sponsor
- Scynexis, Inc.
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Area under the plasma concentration versus time curve (AUC) of Ibrexafungerp
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Single dose of [14^C]-Ibrexafungerp
Each subject will receive a dose of \[14C\]-Ibrexafungerp at 12 h intervals for 7 doses in total.
Intervention: Ibrexafungerp
Outcomes
Primary Outcomes
Area under the plasma concentration versus time curve (AUC) of Ibrexafungerp
Time Frame: Day1 and Day 4
Area under the plasma concentration versus time curve (AUC) will be estimated where possible
Mass balance recovery
Time Frame: 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)
Area under the plasma concentration versus time curve (AUC) of total radioactivity
Time Frame: Day 1 and Day 4
Area under the plasma concentration versus time curve (AUC) of total radioactivity in blood where possible
Peak Plasma Concentration (Cmax) of Ibrexafungerp
Time Frame: Day 1 and Day 4
Peak Plasma Concentration (Cmax) of Ibrexafungerp will be estimated
Metabolite identification in plasma, urine and faeces
Time Frame: Day 26
Determination of primary metabolites using liquid chromatography-radio-detection
Secondary Outcomes
- Routes and rates of elimination of [14^C]-Ibrexafungerp(Day 26)
- Distribution of total radioactivity into blood cells(Day 4)
- Safety of Ibrexafungerp(Day 4)