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

Scynexis

Status and phase: Completed; Phase 1

Conditions: Fungal Infection

Treatments: Drug: [14C]-Ibrexafungerp

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04307082

SCY-078-116

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: Male

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Ibrexafungerp

Experimental group

Description:

Oral \[14C\]-Ibrexafungerp Single Dose

Treatment:

Drug: [14C]-Ibrexafungerp