Status:
COMPLETED
ADME Study of [14C]-Ibrexafungerp in Healthy Male Subjects
Lead Sponsor:
Scynexis, Inc.
Collaborating Sponsors:
Inncelerex
Conditions:
Fungal Infection
Eligibility:
MALE
30-65 years
Phase:
PHASE1
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 adm...
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 adm...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
December 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2020
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04307082
Start Date
December 5 2019
End Date
June 30 2020
Last Update
August 14 2020
Active Locations (1)
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1
Quotient Sciences
Nottingham, United Kingdom, NG116Js