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

Scynexis, Inc.6 enrolled

Overview

This is a Phase 1, open-label, single center, non-randomized study to evaluate the absorption, distribution, metabolism and excretion (ADME) of an oral solution of radiolabeled Ibrexafungerp following repeat administration in healthy male subjects. All subjects will undergo preliminary screening procedures, will remain the clinical unit for approximately 26 days and will receive radiolabeled Ibrexafungerp, orally for 3 days.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Fungal Disease

Interventions

IbrexafungerpDRUG

carbon-14 (\[14\^C\])-Ibrexafungerp

Eligibility

Sex: MALEMin age: 30 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy males aged 30 to 65 years willing and able to sign and informed consent. Exclusion Criteria: * Clinically significant medical history or concurrent medical conditions included but not limited to infections, liver or kidney disease * Use of certain concomitant medications * History of smoking or alcohol abuse

Locations (1)

Quotient Sciences Limited

Nottingham, United Kingdom

Outcomes

Primary Outcomes

Mass balance recovery

Mass balance recovery of total radioactivity in urine, faeces and all excreta (urine and faeces): cumulative recovery (CumAe) and cumulative recovery expressed as a percentage of the dose (Cum%Ae)

Time frame: Day 26

Metabolite identification in plasma, urine and faeces

Determination of primary metabolites using liquid chromatography-radio-detection

Time frame: Day 26

Area under the plasma concentration versus time curve (AUC) of Ibrexafungerp

Area under the plasma concentration versus time curve (AUC) will be estimated where possible

Time frame: Day1 and Day 4

Area under the plasma concentration versus time curve (AUC) of total radioactivity

Area under the plasma concentration versus time curve (AUC) of total radioactivity in blood where possible

Time frame: Day 1 and Day 4

Peak Plasma Concentration (Cmax) of Ibrexafungerp

Peak Plasma Concentration (Cmax) of Ibrexafungerp will be estimated

Time frame: Day 1 and Day 4

Secondary Outcomes

Routes and rates of elimination of [14^C]-Ibrexafungerp

Determination of routes and rates of elimination of \[14C\]-Ibrexafungerp primarily by Ae total radioactivity for urine and faeces.

Time frame: Day 26

Distribution of total radioactivity into blood cells

Evaluation of whole blood plasma concentration ratios for total radioactivity

Time frame: Day 4

Data from ClinicalTrials.gov

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