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

• Status: Completed
• Trial end date: 2020-06-30
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Scynexis, Inc.
• Collaborator: Inncelerex
• Treatments: Ibrexafungerp

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