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

NCT ID: NCT04307082

Last Updated: 2020-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-05
• Study Completion Date: 2020-06-30

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.

Conditions

Fungal Infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Ibrexafungerp

Oral \[14C\]-Ibrexafungerp Single Dose

Group Type: EXPERIMENTAL

[14C]-Ibrexafungerp

Intervention Type: DRUG

Radio-labeled Ibrexafungerp, single dose.

Interventions

[14C]-Ibrexafungerp

Radio-labeled Ibrexafungerp, single dose.

Intervention Type: DRUG

Other Intervention Names

[14C]-SCY-078

Eligibility Criteria

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

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Inncelerex

UNKNOWN

Sponsor Role: collaborator

Scynexis, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nkechi Azie, MD

Role: STUDY_DIRECTOR

Scynexis, Inc.

Locations

Quotient Sciences

Nottingham, , United Kingdom

Countries

United Kingdom

Other Identifiers

SCY-078-116

Identifier Type: -

Identifier Source: org_study_id