Healthy
Conditions
Brief summary
This is a single-dose, single center, single-period, open-label, non-randomized, mass balance recovery study in healthy male subjects.
Interventions
DRUG14C labeled PXL770
Single administration
Sponsors
Poxel SA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
30 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mass balance recovery | From day 1 to day 7 | Mass balance recovery of total radioactivity in all excreta: cumulative recovery (CumAe) and cumulative recovery expressed as a percentage of the dose (Cum%Ae) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PK profile of total radioactivity | From day 1 to day 7 | Cmax |
| PK profile of PXL770 | From day 1 to day 7 | Cmax |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | From day 1 to day 7 | Incidence of Treatment-Emergent Adverse Events |
Countries
United Kingdom
Outcome results
None listed