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

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.

Study Overview

• Status: Completed
• Conditions: Fungal Infection
• Intervention / Treatment: Drug: [14C]-Ibrexafungerp

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 Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham, United Kingdom, NG116Js
    • Quotient Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ibrexafungerp; Oral [14C]-Ibrexafungerp Single Dose	Drug: [14C]-Ibrexafungerp; Radio-labeled Ibrexafungerp, single dose.; Other Names: [14C]-SCY-078

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mass balance	Amount recovered expressed as a percentage of the dose administered	Day 20

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Scynexis, Inc.
• Collaborators: Inncelerex
• Investigators: Study Director: Nkechi Azie, MD, Scynexis, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2019
• Primary Completion (Actual): May 29, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: March 4, 2020
• First Submitted That Met QC Criteria: March 12, 2020
• First Posted (Actual): March 13, 2020

Study Record Updates

• Last Update Posted (Actual): August 14, 2020
• Last Update Submitted That Met QC Criteria: August 12, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: ADME; SCY-078; Ibrexafungerp
• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Mycoses; Anti-Infective Agents; Antifungal Agents; Ibrexafungerp
• Other Study ID Numbers: SCY-078-116

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No