Pharmacokinetics and Metabolism of (14C)-Labelled PXL770

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: 14C labeled PXL770

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham, United Kingdom
    • Quotient

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy volunteer; Single of 14C-PXL770	Drug: 14C labeled PXL770; Single administration

What is the study measuring?

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
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Incidence of Treatment-Emergent Adverse Events	From day 1 to day 7
PK profile of total radioactivity	Cmax	From day 1 to day 7
PK profile of PXL770	Cmax	From day 1 to day 7

Collaborators and Investigators

• Sponsor: Poxel SA

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2019
• Primary Completion (Actual): March 15, 2019
• Study Completion (Actual): March 15, 2019

Study Registration Dates

• First Submitted: March 20, 2019
• First Submitted That Met QC Criteria: March 20, 2019
• First Posted (Actual): March 22, 2019

Study Record Updates

• Last Update Posted (Actual): March 22, 2019
• Last Update Submitted That Met QC Criteria: March 20, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: PXL770-005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No