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

• Status: Recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Scynexis, Inc.
• Treatments: Ibrexafungerp

Criteria

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