Fungal disease Infections and Infestations
Conditions
Interventions
This non-randomised study will consist of a single study period involving up to 6 male volunteers, aged 30-65 years old. There is no placebo. All subjects will receive the same treatment. Each volunte
Sponsors
Scynexis (United States)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Must provide written informed consent 2. Must be willing and able to communicate and participate in the whole study 3. Aged 30 to 65 years inclusive at the time of signing informed consent 4. Must agree to adhere to the contraception requirements defined in the protocol 5. Healthy males 6. Body mass index (BMI) of 18.0 kg/m2 to 30.0 kg/m2 as measured at screening 7. Must have regular bowel movements (i.e. average stool production of =1 and =3 stools per day)
Exclusion criteria
Exclusion criteria: 1. Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients 2. Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active 3. History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory, haematological or GI disease, neurological or psychiatric disorder, irritable bowel syndrome, gastritis, intermittent vomitus or diarrhoea as judged by the investigator 4. Influenza or a viral infection within the 30 days prior to first IMP administration 5. Acute diarrhoea or constipation in the 7 days before the predicted first study day. If screening occurs >7 days before admission, this criterion will be determined admission/pre-first dose. Diarrhoea will be defined as the passage of liquid faeces and/or a stool frequency of greater than 3 times per day. Constipation will be defined as a failure to open the bowels more frequently than every other day 6. Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening 7. Evidence of current SARS-CoV-2 infection 8. Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the investigator. Subjects with Gilbert’s Syndrome are not allowed 9. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or HIV 1 and 2 antibody results 10. Subjects with ALT or AST or bilirubin values >ULN at screening 11. Haemoglobin or platelet count values <LLN at screening 12. Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance (CLcr) of <80 mL/min using the Cockcroft-Gault equation 13. Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1, or less than 5 elimination half-lives prior to Day 1, whichever is longer 14. Subjects who report to have previously received ibrexafungerp, including in SCY-078-116 (QSC202765) 15. Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017, shall participate in the study 16. Subjects who have been administered IMP in an ADME study in the last 12 months 17. Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood 18. Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies (other than up to 4 g of paracetamol per day) in the 14 days before first IMP administration on Day 1 (see Section 11.4). Vaccines are not accepted concomitant medications. Exceptions may apply, as determined by the investigator, if each of the following criteria are met: medication with a short half-life if the washout is such that no pharmacodynamic activity is expected by the time of dosing with IMP; and if the use of medication does not jeopardise the safety of the trial subject; and if the use of medication is not cons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Mass balance recovery of total radioactivity in urine, faeces and all excreta of the test medicine from the body measured using liquid scintillation counting from samples taken from Day 1 up to Day 26 2. Identify breakdown products of the test medicine in excreta measured using liquid chromatography with radio detection and high-resolution mass spectrometry from samples taken from Day 1 up to Day 26 3. Pharmacokinetics of the test medicine in plasma and whole blood measured in blood samples taken for LC-MS/MS assay of the test medicine from Day 1 up to Day 26 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Identification of the chemical structure of each metabolite (breakdown product) accounting for more than 10% by AUC of plasma total radioactivity or accounting for 10% or more of the dose in excreta measured using liquid chromatography with radio detection and high-resolution mass spectrometry of samples taken between Day 1 up to Day 26 2. The pharmacokinetics of the test medicine and its metabolites in plasma measured in blood samples taken for LC-MS/MS assay of the test medicine, using samples taken between Day 1 to Day 26 3. Evaluation of whole blood:plasma concentration ratios for total radioactivity (to evaluate the extent of distribution of total radioactivity into blood cells), using samples taken between Day 1 up to Day 26 for LC-MS/MS assay of the test medicine 4. Adverse events (to assess tolerability of the test medicine) will be collected by asking volunteers how they are feeling, from the start of the trial until follow-up. Other safety measures (including vital signs, ECGs and laboratory safety tests) will also be assessed by standard phase I unit monitoring, at screening, from Day 1 to discharge from the ward. | — |
Countries
England, United Kingdom
Contacts
Public ContactGlen Park
Outcome results
None listed