A phase I, 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

Scynexis (United States)0 sites6 target enrollmentDecember 14, 2022

ConditionsFungal disease Infections and Infestations

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Fungal disease
Sponsor: Scynexis (United States)
Enrollment: 6
Status: Active, not recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

December 14, 2022

End Date

January 27, 2023

Last Updated

3 years ago

Study Type

Interventional

Sex

Male

Investigators

Sponsor

Scynexis (United States)

Eligibility 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

•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