ADME Study of [14^C]-Ibrexafungerp in Healthy Male Subjects

Fungal Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05668429
• Other study ID #: SCY-078-122
• Status: Completed
• Phase: Phase 1
• Start date: December 14, 2022
• Est. completion date: January 28, 2023

Study information

• Verified date: June 2023
• Source: Scynexis, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: January 28, 2023
• Est. primary completion date: January 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fungal Disease
• Mycoses

Intervention

Drug:
• Ibrexafungerp
carbon-14 ([14^C])-Ibrexafungerp

Locations

Country	Name	City	State
United Kingdom	Quotient Sciences Limited	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Scynexis, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Metabolite identification in plasma, urine and faeces	Determination of primary metabolites using liquid chromatography-radio-detection	Day 26
Primary	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
Primary	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
Primary	Peak Plasma Concentration (Cmax) of Ibrexafungerp	Peak Plasma Concentration (Cmax) of Ibrexafungerp will be estimated	Day 1 and Day 4
Secondary	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
Secondary	Distribution of total radioactivity into blood cells	Evaluation of whole blood plasma concentration ratios for total radioactivity	Day 4
Secondary	Safety of Ibrexafungerp	Number of participants with treatment-related adverse events as assessed by the investigator.	Day 4