Skip to main content
OpenTrials
Completed

NCT Number: NCT05668429

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Fungal Disease Bacterial Infections and Mycoses Infections Mycoses

Age range

30 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Quotient Sciences Limited

Nottingham, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IBREXAFUNGERP

Drug

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

Primary outcomes

  1. Mass balance recovery

    Time frame: Day 26

    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)

  2. Metabolite identification in plasma, urine and faeces

    Time frame: Day 26

    Determination of primary metabolites using liquid chromatography-radio-detection

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

    Time frame: Day1 and Day 4

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

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

    Time frame: Day 1 and Day 4

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

  5. Peak Plasma Concentration (Cmax) of Ibrexafungerp

    Time frame: Day 1 and Day 4

    Peak Plasma Concentration (Cmax) of Ibrexafungerp will be estimated

Secondary outcomes

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

    Time frame: Day 26

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

  2. Distribution of total radioactivity into blood cells

    Time frame: Day 4

    Evaluation of whole blood plasma concentration ratios for total radioactivity

  3. Safety of Ibrexafungerp

    Time frame: Day 4

    Number of participants with treatment-related adverse events as assessed by the investigator.

Sponsors and collaborators

Lead sponsor

Scynexis, Inc.

Industry

Registry information

Official study title

A Phase 1, Open-Label, Single-Centre Study to Evaluate the Absorption, Distribution, Metabolism and Excretion (ADME) of Oral [14^C]-Ibrexafungerp in Healthy Male Subjects After Repeat Dosing

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 29, 2022
Registry last updated
Jun 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.