ADME Study of [14C]-Ibrexafungerp in Healthy Male Subjects | NCT04307082

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

NCT04307082

Sponsor

Scynexis, Inc.

Status

Completed

Last Update Posted

Aug 14, 2020Actual

Enrollment

6Actual

Phase

Phase 1

Conditions

Fungal Infection

Interventions

[14C]-Ibrexafungerp

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 5, 2019Actual

Primary Completion Date

May 29, 2020Actual

Completion Date

Jun 30, 2020Actual

First Submitted Date

Mar 4, 2020

First Submission Date that Met QC Criteria

Mar 12, 2020

First Posted Date

Mar 13, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 12, 2020

Last Update Posted Date

Aug 14, 2020Actual

Name	Class
Inncelerex	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ibrexafungerp	Experimental	Oral [14C]-Ibrexafungerp Single Dose	Drug: [14C]-Ibrexafungerp

Interventions

Name	Type	Description	Arm Group Labels	Other Names
[14C]-Ibrexafungerp	Drug	Radio-labeled Ibrexafungerp, single dose.	Ibrexafungerp

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mass balance	Amount recovered expressed as a percentage of the dose administered	Day 20

Secondary Outcomes

Measure	Description	Time Frame
Routes and rates of elimination of [14C]-ibrexafungerp	Metabolite concentrations in body fluids and excreta	Day 20
Number of subjects with treatment-emergent adverse events	Number of subjects with treatment-emergent adverse events

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Nkechi Azie, MD	Scynexis, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Quotient Sciences		Nottingham		NG116Js	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D001423	Bacterial Infections and Mycoses
D007239	Infections