Pharmacokinetics and Metabolism of (14C)-Labelled PXL770

Poxel

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: 14C labeled PXL770

Study type: Interventional

Funder types: Industry

Identifiers

NCT03886103

PXL770-005

Details and patient eligibility

About

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

Enrollment: 8 patients

Sex: Male

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Healthy volunteer

Experimental group

Description:

Single of 14C-PXL770

Treatment:

Drug: 14C labeled PXL770