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

Sponsor

Scynexis, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05668429

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Fungal Disease	Drug: Ibrexafungerp	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

6 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

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

Anticipated Study Start Date :

Dec 1, 2022

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single dose of [14^C]-Ibrexafungerp Each subject will receive a dose of [14C]-Ibrexafungerp at 12 h intervals for 7 doses in total.	Drug: Ibrexafungerp carbon-14 ([14^C])-Ibrexafungerp

Arm

Intervention/Treatment

Experimental: Single dose of [14^C]-Ibrexafungerp

Each subject will receive a dose of [14C]-Ibrexafungerp at 12 h intervals for 7 doses in total.

Drug: Ibrexafungerp

carbon-14 ([14^C])-Ibrexafungerp

Outcome Measures

Primary Outcome Measures

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)
Metabolite identification in plasma, urine and faeces [Day 26]
Determination of primary metabolites using liquid chromatography-radio-detection
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

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 65 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Quotient Sciences Limited	Nottingham		United Kingdom

Sponsors and Collaborators

Scynexis, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Scynexis, Inc.

ClinicalTrials.gov Identifier:

NCT05668429

Other Study ID Numbers:

SCY-078-122

First Posted:

Dec 29, 2022

Last Update Posted:

Dec 29, 2022

Last Verified:

Dec 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Mycoses

Ibrexafungerp

Study Results

No Results Posted as of Dec 29, 2022