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

June 27, 2023 updated by: Scynexis, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Day 26
Metabolite identification in plasma, urine and faeces
Time Frame: Day 26
Determination of primary metabolites using liquid chromatography-radio-detection
Day 26
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
Day1 and Day 4
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
Day 1 and Day 4
Peak Plasma Concentration (Cmax) of Ibrexafungerp
Time Frame: Day 1 and Day 4
Peak Plasma Concentration (Cmax) of Ibrexafungerp will be estimated
Day 1 and Day 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Routes and rates of elimination of [14^C]-Ibrexafungerp
Time Frame: Day 26
Determination of routes and rates of elimination of [14C]-Ibrexafungerp primarily by Ae total radioactivity for urine and faeces.
Day 26
Distribution of total radioactivity into blood cells
Time Frame: Day 4
Evaluation of whole blood plasma concentration ratios for total radioactivity
Day 4
Safety of Ibrexafungerp
Time Frame: Day 4
Number of participants with treatment-related adverse events as assessed by the investigator.
Day 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Scynexis, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2022

Primary Completion (Actual)

January 28, 2023

Study Completion (Actual)

January 28, 2023

Study Registration Dates

First Submitted

December 8, 2022

First Submitted That Met QC Criteria

December 20, 2022

First Posted (Actual)

December 29, 2022

Study Record Updates

Last Update Posted (Actual)

June 28, 2023

Last Update Submitted That Met QC Criteria

June 27, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCY-078-122

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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