Pharmacokinetics and Metabolism of (14C)-Labelled PXL770

Study Overview
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Brief Summary
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This is a single-dose, single center, single-period, open-label, non-randomized, mass balance recovery study in healthy male subjects.

Official Title
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Pharmacokinetics and Metabolism of [14C]-Labelled PXL770 Following a Single Oral Administration in Healthy Male Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: 14C labeled PXL770


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Caucasian males Age 30 to 65 years BMI 18.5 to 32.0 kg/m2 and body weight of 55 to 95 kg. Must be willing and able to communicate and participate in the whole study Must have regular bowel movements (ie, average stool production of ≥1 and ≤3 stools per day) Must provide written informed consent Regular alcohol consumption of 4-14 units of alcohol 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) Must agree to adhere to the contraception Exclusion Criteria: Subjects who have received any IMP in a clinical research study within the previous 3 months or 90 days prior to Day 1 any drug or alcohol abuse Current smokers and those who have smoked within the last 12 months. Radiation exposure, including that from the present study, excluding background adiation 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 exposedworker, as defined in the Ionizing Radiation Regulations 2017, shall participate in the study Clinically significant abnormal biochemistry, hematology, coagulation or urinalysis as judged by the investigator Positive test for HIV, HBV, HBC eGFR <80 mL/min History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or GI disease, neurological or psychiatric disorder, as judged by the investigator Known sensitivity to any of the constituents or excipients of the study drug or history of relevant drug and/or food allergy (anaphylactic, anaphylactoid reactions) History of drug-induced Torsade de Pointe or presence of a familial long QT syndrome Mental handicap

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy volunteer<br>Single of 14C-PXL770 | Drug: 14C labeled PXL770<br>* Single administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mass balance recovery | Mass balance recovery of total radioactivity in all excreta: cumulative recovery (CumAe) and cumulative recovery expressed as a percentage of the dose (Cum%Ae) | From day 1 to day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK profile of total radioactivity | Cmax | From day 1 to day 7 | 
| PK profile of PXL770 | Cmax | From day 1 to day 7 | 
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Incidence of Treatment-Emergent Adverse Events | From day 1 to day 7 |