NCT05668429

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Scynexis, Inc. · Industry
• Sex: Male
• Age: 30 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Fungal Disease

Interventions

Type	Name	Description
DRUG	Ibrexafungerp	carbon-14 (\[14\^C\])-Ibrexafungerp

Timeline

• Start date: 2022-12-14
• Primary completion: 2023-01-28
• Completion: 2023-01-28
• First posted: 2022-12-29
• Last updated: 2023-06-28

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study