Pharmacokinetics and Metabolism of (14C)-Labelled PXL770

NCT ID: NCT03886103

Last Updated: 2019-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-06
• Study Completion Date: 2019-03-15

Brief Summary

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

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Healthy volunteer

Single of 14C-PXL770

Group Type: EXPERIMENTAL

14C labeled PXL770

Intervention Type: DRUG

Single administration

Interventions

14C labeled PXL770

Single administration

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Poxel SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Quotient

Nottingham, , United Kingdom

Countries

United Kingdom

Other Identifiers

PXL770-005

Identifier Type: -

Identifier Source: org_study_id