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

Scynexis

Status and phase: Completed; Phase 1

Conditions: Fungal Disease

Treatments: Drug: Ibrexafungerp

Study type: Interventional

Funder types: Industry

Identifiers

NCT05668429

SCY-078-122

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: Male

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Single dose of [14^C]-Ibrexafungerp

Experimental group

Description:

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

Treatment:

Drug: Ibrexafungerp