Status:
COMPLETED
A Study to Assess the Mass Balance Recovery and Metabolite Profile & Identification of [14C]-APX001 in Healthy Males
Lead Sponsor:
Basilea Pharmaceutica
Conditions:
Fungal Infection
Eligibility:
MALE
30-65 years
Phase:
PHASE1
Brief Summary
This is a single-center, open-label, non-randomized, single dose study in healthy male subjects. It was planned to enroll 2 cohorts of 5 subjects (10 subjects in total), with the target of achieving d...
Eligibility Criteria
Inclusion
- Healthy males
- Aged 30 to 65 years of age
- Body mass index (BMI) of 18.0 to 32.0 kg/m2 or, if outside the range, considered not clinically significant by the investigator
- Good state of health (mentally and physically) as indicated by a comprehensive clinical assessment (detailed medical history and a complete physical examination)
- Must have been willing and able to communicate and participate in the whole study
- Must have had regular bowel movements (i.e. average stool production of ≥1 and
- ≤3 stools per day)
- Must have provided written informed consent
- Must have adhered to the contraception requirements defined in Section 9.4 of the protocol (Appendix 16.1.1)
Exclusion
- Subjects who had received any IMP in a clinical research study within the previous 3 months or a similar 14C radioactive clinical trial within the previous 12 months
- Subjects who were study site employees, or immediate family members of a study site or sponsor employee
- Subjects who had previously been enrolled in this study.
- History of any drug or alcohol abuse in the past 2 years
- Regular alcohol consumption in males \>21 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 units = 125 mL glass of wine, depending on type)
- Current smokers and those who had smoked within the last 12 months. A breath carbon monoxide (CO) reading of greater than 10 ppm at screening and admission
- Current users of e-cigarettes and nicotine replacement products and those who had used these products within the last 12 months
- Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeded 5 millisieverts (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, was to participate in the study
- Subjects who did not have suitable veins for multiple venipunctures/cannulation as assessed by the investigator at screening
- Clinically significant abnormality on electrocardiogram (ECG) as judged by the investigator
- Clinically significant abnormal biochemistry, hematology or urinalysis at screening as judged by the investigator (laboratory parameters are listed in Appendix 1 of the protocol, Appendix 16.1.1)
- Positive drugs of abuse test result (drugs of abuse tests are listed in Appendix 1 of the protocol, Appendix 16.1.1)
- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
- Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance of \<80 mL/min using the Cockcroft-Gault equation
- History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal (GI) disease, neurological or psychiatric disorder, as judged by the investigator
- Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
- Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hayfever was allowed unless it was active
- Donation or loss of greater than 400 mL of blood within the previous 3 months
- Subjects who were taking, or had taken, any prescribed or over-the-counter drug (other than 4 g per day paracetamol) or herbal remedies in the 14 days before IMP administration (see Section 11.4 of the protocol, Appendix 16.1.1). Exceptions may have applied on a case by case basis, if considered not to interfere with the objectives of the study, as agreed by the PI and sponsor's medical monitor.
- Failure to satisfy the investigator of fitness to participate for any other reason
Key Trial Info
Start Date :
August 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 26 2018
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04804059
Start Date
August 17 2018
End Date
September 26 2018
Last Update
May 17 2024
Active Locations (1)
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1
Quotient Sciences
Ruddington, Nottingham, United Kingdom, NG11 6JS