Pharmacokinetics and Metabolism of (14C)-Labelled PXL770

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: 14C labeled PXL770

• Registration Number: NCT03886103
• Lead Sponsor: Poxel SA

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-06
• Status Verified: 2019-03
• Primary Completion: 2019-03-15
• Study Completion: 2019-03-15
• Study First Submitted: 2019-03-20
• Study First Submitted QC: 2019-03-20
• Last Update Submitted: 2019-03-20
• Study First Posted: 2019-03-22
• Last Update Posted: 2019-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy volunteer	14C labeled PXL770	Single of 14C-PXL770

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
PK profile of PXL770	From day 1 to day 7	Cmax
PK profile of total radioactivity	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

Trial Locations

Locations (1)

Quotient; 🇬🇧 Nottingham, United Kingdom