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

NCT05668429 | Completed Phase 1 FDA Drug

• 1 other identifier: SCY-078-122
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fungal Disease

Outcome Measures

Primary Outcomes (5)

• 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)

  Day 26

• Metabolite identification in plasma, urine and faeces

  Determination of primary metabolites using liquid chromatography-radio-detection

  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

  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

  Day 1 and Day 4

• Peak Plasma Concentration (Cmax) of Ibrexafungerp

  Peak Plasma Concentration (Cmax) of Ibrexafungerp will be estimated

  Day 1 and Day 4

Secondary Outcomes (3)

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

  Day 26

• Distribution of total radioactivity into blood cells

  Day 4

• Safety of Ibrexafungerp

  Day 4

Study Arms (1)

Single dose of [14^C]-Ibrexafungerp

EXPERIMENTAL

Each subject will receive a dose of \[14C\]-Ibrexafungerp at 12 h intervals for 7 doses in total.

Drug: Ibrexafungerp

Interventions

Ibrexafungerp DRUG

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

Single dose of [14^C]-Ibrexafungerp

Eligibility Criteria

• Age: 30 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy males aged 30 to 65 years willing and able to sign and informed consent.

You may not qualify if:

• 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

Sponsors & Collaborators

• Scynexis, Inc.: lead

Study Sites (1)

Quotient Sciences Limited

Nottingham, United Kingdom

Location

MeSH Terms

Conditions

Mycoses

Interventions

ibrexafungerp

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2022
• First Posted: December 29, 2022
• Study Start: December 14, 2022
• Primary Completion: January 28, 2023
• Study Completion: January 28, 2023
• Last Updated: June 28, 2023

Record last verified: 2023-06

Locations

GB (1)