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

Fungal Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04307082
• Other study ID #: SCY-078-116
• Status: Completed
• Phase: Phase 1
• Start date: December 5, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: August 2020
• Source: Scynexis, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: June 30, 2020
• Est. primary completion date: May 29, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 65 Years

Eligibility

Key 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

Related Conditions & MeSH terms

• Fungal Infection
• Mycoses

Intervention

Drug:
• [14C]-Ibrexafungerp
Radio-labeled Ibrexafungerp, single dose.

Locations

Country	Name	City	State
United Kingdom	Quotient Sciences	Nottingham

Sponsors (2)

Lead Sponsor	Collaborator
Scynexis, Inc.	Inncelerex

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mass balance	Amount recovered expressed as a percentage of the dose administered	Day 20
Secondary	Routes and rates of elimination of [14C]-ibrexafungerp	Metabolite concentrations in body fluids and excreta	Day 20
Secondary	Number of subjects with treatment-emergent adverse events	Number of subjects with treatment-emergent adverse events	Day 20