Trial | NCT04307082  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    6
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.
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.
Study Started
Dec 05
2019
Primary Completion
May 29
2020
Study Completion
Jun 30
2020
Last Update
Aug 14
2020

Drug [14C]-Ibrexafungerp

Radio-labeled Ibrexafungerp, single dose.

  • Other names: [14C]-SCY-078

Ibrexafungerp Experimental

Oral [14C]-Ibrexafungerp Single Dose

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
No Results Posted