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

Primary Purpose

Fungal Infection

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
[14C]-Ibrexafungerp
Sponsored by
Scynexis, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Fungal Infection focused on measuring SCY-078, Ibrexafungerp, ADME

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Quotient Sciences

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ibrexafungerp

Arm Description

Oral [14C]-Ibrexafungerp Single Dose

Outcomes

Primary Outcome Measures

Mass balance
Amount recovered expressed as a percentage of the dose administered

Secondary Outcome Measures

Routes and rates of elimination of [14C]-ibrexafungerp
Metabolite concentrations in body fluids and excreta
Number of subjects with treatment-emergent adverse events
Number of subjects with treatment-emergent adverse events

Full Information

First Posted
March 4, 2020
Last Updated
August 12, 2020
Sponsor
Scynexis, Inc.
Collaborators
Inncelerex
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1. Study Identification

Unique Protocol Identification Number
NCT04307082
Brief Title
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

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
December 5, 2019 (Actual)
Primary Completion Date
May 29, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Scynexis, Inc.
Collaborators
Inncelerex

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fungal Infection
Keywords
SCY-078, Ibrexafungerp, ADME

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Open Label, single arm
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ibrexafungerp
Arm Type
Experimental
Arm Description
Oral [14C]-Ibrexafungerp Single Dose
Intervention Type
Drug
Intervention Name(s)
[14C]-Ibrexafungerp
Other Intervention Name(s)
[14C]-SCY-078
Intervention Description
Radio-labeled Ibrexafungerp, single dose.
Primary Outcome Measure Information:
Title
Mass balance
Description
Amount recovered expressed as a percentage of the dose administered
Time Frame
Day 20
Secondary Outcome Measure Information:
Title
Routes and rates of elimination of [14C]-ibrexafungerp
Description
Metabolite concentrations in body fluids and excreta
Time Frame
Day 20
Title
Number of subjects with treatment-emergent adverse events
Description
Number of subjects with treatment-emergent adverse events
Time Frame
Day 20

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nkechi Azie, MD
Organizational Affiliation
Scynexis, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Quotient Sciences
City
Nottingham
ZIP/Postal Code
NG116Js
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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