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

Phase 1

Completed

• Conditions: Fungal Infection
• Interventions: Drug: [14C]-Ibrexafungerp

• Registration Number: NCT04307082
• Lead Sponsor: Scynexis, Inc.

Brief 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.

Study Timeline

• Study Start: 2019-12-05
• Study First Submitted: 2020-03-04
• Study First Submitted QC: 2020-03-12
• Study First Posted: 2020-03-13
• Primary Completion: 2020-05-29
• Study Completion: 2020-06-30
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-12
• Last Update Posted: 2020-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

Inclusion Criteria

• Healthy males
• Age 30 to 65 years of age at the time of signing informed consent
• Must be willing and able to participate in the whole study
• Must provide written informed consent
• Must agree to adhere to the contraception requirements

Key

Exclusion Criteria

• Subjects who have received any investigational drug in a clinical research study within the 90 days prior to Day 1
• Current smokers
• Recent radiation exposure
• Subjects who have been enrolled in a 14C ADME study in the last 12 months
• An acute or chronic disease determined by the investigator to be clinically significant
• Clinically significant abnormal clinical chemistry, haematology, coagulation or urinalysis at screening as judged by the investigator
• Evidence of renal impairment at screening
• History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ibrexafungerp	[14C]-Ibrexafungerp	Oral \[14C\]-Ibrexafungerp Single Dose

Primary Outcome Measures

Name	Time	Method
Mass balance	Day 20	Amount recovered expressed as a percentage of the dose administered

Secondary Outcome Measures

Name	Time	Method
Number of subjects with treatment-emergent adverse events	Day 20	Number of subjects with treatment-emergent adverse events
Routes and rates of elimination of [14C]-ibrexafungerp	Day 20	Metabolite concentrations in body fluids and excreta

Trial Locations

Locations (1)

Quotient Sciences; 🇬🇧 Nottingham, United Kingdom