Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 14 for:    scynexis

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04307082
Recruitment Status : Active, not recruiting
First Posted : March 13, 2020
Last Update Posted : March 13, 2020
Sponsor:
Collaborator:
Inncelerex
Information provided by (Responsible Party):
Scynexis, Inc.

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.


Condition or disease Intervention/treatment Phase
Fungal Infection Drug: [14C]-Ibrexafungerp Phase 1

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Open Label, single arm
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : December 5, 2019
Estimated Primary Completion Date : May 29, 2020
Estimated Study Completion Date : July 31, 2020

Arm Intervention/treatment
Experimental: Ibrexafungerp
Oral [14C]-Ibrexafungerp Single Dose
Drug: [14C]-Ibrexafungerp
Radio-labeled Ibrexafungerp, single dose.
Other Name: [14C]-SCY-078




Primary Outcome Measures :
  1. Mass balance [ Time Frame: Day 20 ]
    Amount recovered expressed as a percentage of the dose administered


Secondary Outcome Measures :
  1. Routes and rates of elimination of [14C]-ibrexafungerp [ Time Frame: Day 20 ]
    Metabolite concentrations in body fluids and excreta

  2. Number of subjects with treatment-emergent adverse events [ Time Frame: Day 20 ]
    Number of subjects with treatment-emergent adverse events



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04307082


Locations
Layout table for location information
United Kingdom
Quotient Sciences
Nottingham, United Kingdom, NG116Js
Sponsors and Collaborators
Scynexis, Inc.
Inncelerex
Investigators
Layout table for investigator information
Study Director: Nkechi Azie, MD Scynexis, Inc.

Layout table for additonal information
Responsible Party: Scynexis, Inc.
ClinicalTrials.gov Identifier: NCT04307082    
Other Study ID Numbers: SCY-078-116
First Posted: March 13, 2020    Key Record Dates
Last Update Posted: March 13, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Scynexis, Inc.:
SCY-078
Ibrexafungerp
ADME
Additional relevant MeSH terms:
Layout table for MeSH terms
Mycoses