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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-14

Study Completion Date

2023-01-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Fungal Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Single dose of [14^C]-Ibrexafungerp

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

Group Type EXPERIMENTAL

Ibrexafungerp

Intervention Type DRUG

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

Interventions

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Ibrexafungerp

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes