Back to resultsADME Study of [14^C]-Ibrexafungerp in Healthy Male Subjects
Primary Purpose
Fungal Disease
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Ibrexafungerp
Sponsored by
About this trial
This is an interventional other trial for Fungal Disease
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
Sites / Locations
- Quotient Sciences Limited
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single dose of [14^C]-Ibrexafungerp
Arm Description
Each subject will receive a dose of [14C]-Ibrexafungerp at 12 h intervals for 7 doses in total.
Outcomes
Primary Outcome Measures
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)
Metabolite identification in plasma, urine and faeces
Determination of primary metabolites using liquid chromatography-radio-detection
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
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
Peak Plasma Concentration (Cmax) of Ibrexafungerp
Peak Plasma Concentration (Cmax) of Ibrexafungerp will be estimated
Secondary Outcome Measures
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.
Distribution of total radioactivity into blood cells
Evaluation of whole blood plasma concentration ratios for total radioactivity
Safety of Ibrexafungerp
Number of participants with treatment-related adverse events as assessed by the investigator.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05668429
Brief Title
ADME Study of [14^C]-Ibrexafungerp in Healthy Male Subjects
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
December 14, 2022 (Actual)
Primary Completion Date
January 28, 2023 (Actual)
Study Completion Date
January 28, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Scynexis, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fungal Disease
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single dose of [14^C]-Ibrexafungerp
Arm Type
Experimental
Arm Description
Each subject will receive a dose of [14C]-Ibrexafungerp at 12 h intervals for 7 doses in total.
Intervention Type
Drug
Intervention Name(s)
Ibrexafungerp
Intervention Description
carbon-14 ([14^C])-Ibrexafungerp
Primary Outcome Measure Information:
Title
Mass balance recovery
Description
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)
Time Frame
Day 26
Title
Metabolite identification in plasma, urine and faeces
Description
Determination of primary metabolites using liquid chromatography-radio-detection
Time Frame
Day 26
Title
Area under the plasma concentration versus time curve (AUC) of Ibrexafungerp
Description
Area under the plasma concentration versus time curve (AUC) will be estimated where possible
Time Frame
Day1 and Day 4
Title
Area under the plasma concentration versus time curve (AUC) of total radioactivity
Description
Area under the plasma concentration versus time curve (AUC) of total radioactivity in blood where possible
Time Frame
Day 1 and Day 4
Title
Peak Plasma Concentration (Cmax) of Ibrexafungerp
Description
Peak Plasma Concentration (Cmax) of Ibrexafungerp will be estimated
Time Frame
Day 1 and Day 4
Secondary Outcome Measure Information:
Title
Routes and rates of elimination of [14^C]-Ibrexafungerp
Description
Determination of routes and rates of elimination of [14C]-Ibrexafungerp primarily by Ae total radioactivity for urine and faeces.
Time Frame
Day 26
Title
Distribution of total radioactivity into blood cells
Description
Evaluation of whole blood plasma concentration ratios for total radioactivity
Time Frame
Day 4
Title
Safety of Ibrexafungerp
Description
Number of participants with treatment-related adverse events as assessed by the investigator.
Time Frame
Day 4
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Quotient Sciences Limited
City
Nottingham
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
ADME Study of [14^C]-Ibrexafungerp in Healthy Male Subjects
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