*A Phase I ADME Study in Healthy Volunteers (QSC207159)
Research type
Research Study
Full 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 After Repeat Dosing
IRAS ID
1006333
Contact name
Glen Park
Contact email
Sponsor organisation
SCYNEXIS Inc.
Eudract number
2022-002824-10
Clinicaltrials.gov Identifier
Research summary
The Sponsor is developing the test medicine, ibrexafungerp, for the potential treatment and prevention of fungal infections. Fungal infections are diseases caused by fungi, a type of living organism. These diseases most commonly affect the skin, hair, or nails. More serious fungal infections can develop inside the body’s organs, and these may need to be treated in hospital.
This single-part, healthy volunteer study will try to identify how the test medicine is taken up, broken down and removed from the body. To help investigate this, the test medicine is radiolabelled, which means that it has a radioactive component (carbon-14) which helps us to track where the test medicine is in the body. The test medicine’s safety and tolerability will also be studied.
This study will take place at one non-NHS site, and will consist of a single study period involving up to 6 male volunteers, aged 30-65 years.
On Days 1, 2 and 3 volunteers will receive a single oral dose of the radiolabelled test medicine in the fasted state (on an empty stomach) on two occasions, once in the morning and once in the evening. On Day 4, volunteers will receive a final, single oral dose of the radiolabelled test medicine, in the morning, in the fasted state.
Volunteer’s blood, urine and faeces will be taken throughout the study for analysis of the test medicine and its breakdown products (metabolites) and for volunteer safety.
Volunteers will remain in the clinic until Day 15 but may be discharged as a group earlier, or have their stay extended until Day 17 (based on relevant radioactivity criteria being met). If criteria have not been met on Day 17, home collections of urine and/or faeces may be required.
Volunteers are expected to be involved in this study for approximately 8 weeks from screening to discharge.
REC name
London - Brent Research Ethics Committee
REC reference
22/LO/0646
Date of REC Opinion
24 Nov 2022
REC opinion
Further Information Favourable Opinion