NCT04307082

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

A Phase 1, Open-Label, Single-Centre Study to Evaluate the Absorption, Distribution, Metabolism, and Excretion (ADME) of Oral [14C]-Ibrexafungerp in Healthy Male Subjects

• 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-centre, non-randomised study to evaluate the absorption, distribution, metabolism, and excretion (ADME) of an oral solution of \[14C\]-ibrexafungerp following administration in healthy male subjects. Each subject will receive a single dose of \[14C\]-ibrexafungerp and will be followed for up to 20 days. During this period total radioactivity will be measured in blood, urine and faeces.

Detailed description

This is a Phase 1, open-label, single-centre, non-randomised study to evaluate the absorption, distribution, metabolism, and excretion (ADME) of an oral solution of \[14C\]-ibrexafungerp following administration in healthy male subjects. Each subject will receive a single dose of \[14C\]-ibrexafungerp and will be followed for up to 20 days. During this period total radioactivity will be measured in blood, urine and faeces. All subjects will undergo preliminary screening procedures for the study at the screening visit. Subjects will be admitted to the clinical unit on the evening prior to dosing (Day -1). A single oral dose containing \[14C\]-ibrexafungerp oral solution will be administered to subjects. Individual subjects will be released from the clinical unit following study-related procedures on Days 8 to 20 according to their % of radioactivity collected in relation to the dose administered.

Conditions

• Fungal Infection

Interventions

Type	Name	Description
DRUG	[14C]-Ibrexafungerp	Radio-labeled Ibrexafungerp, single dose.

Timeline

• Start date: 2019-12-05
• Primary completion: 2020-05-29
• Completion: 2020-06-30
• First posted: 2020-03-13
• Last updated: 2020-08-14

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study