ADME Study of [14^C]-Ibrexafungerp in Healthy Male Subjects
- Registration Number
- NCT05668429
- Lead Sponsor
- Scynexis, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 6
- Healthy males aged 30 to 65 years willing and able to sign and informed consent.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single dose of [14^C]-Ibrexafungerp Ibrexafungerp Each subject will receive a dose of \[14C\]-Ibrexafungerp at 12 h intervals for 7 doses in total.
- Primary Outcome Measures
Name Time Method 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)
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
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
- Secondary Outcome Measures
Name Time Method 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.
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.
Trial Locations
- Locations (1)
Quotient Sciences Limited
🇬🇧Nottingham, United Kingdom