Clinical trial NCT04307082: ADME Study of [14C]-Ibrexafungerp in Healthy Male Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Fungal Infection
Keywords: SCY-078
Ibrexafungerp
ADME
Lead sponsor: Scynexis, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Inncelerex
First posted: 2020-03-13
Enrollment: 6
Sex: MALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open Label, single arm
Primary purpose: OTHER

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.

Eligibility 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

Primary outcomes:
measure: Mass balance
timeFrame: Day 20
Secondary outcomes:
measure: Routes and rates of elimination of [14C]-ibrexafungerp
timeFrame: Day 20
measure: Number of subjects with treatment-emergent adverse events
timeFrame: Day 20
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Quotient Sciences
Study officials:
affiliation: Scynexis, Inc.
name: Nkechi Azie, MD
role: STUDY_DIRECTOR
References: