Pharmacokinetics and Metabolism of (14C)-Labelled PXL770

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03886103
• Other study ID #: PXL770-005
• Status: Completed
• Phase: Phase 1
• Start date: February 6, 2019
• Est. completion date: March 15, 2019

Study information

• Verified date: March 2019
• Source: Poxel SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: March 15, 2019
• Est. primary completion date: March 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• 14C labeled PXL770
Single administration

Locations

Country	Name	City	State
United Kingdom	Quotient	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Poxel SA

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	PK profile of total radioactivity	Cmax	From day 1 to day 7
Secondary	PK profile of PXL770	Cmax	From day 1 to day 7
Secondary	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Incidence of Treatment-Emergent Adverse Events	From day 1 to day 7