Pharmacokinetics and Metabolism of (14C)-Labelled PXL770

NCT03886103 | Completed Phase 1

• 1 other identifier: PXL770-005
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• PK profile of total radioactivity

  From day 1 to day 7

• PK profile of PXL770

  From day 1 to day 7

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  From day 1 to day 7

Study Arms (1)

Healthy volunteer

EXPERIMENTAL

Single of 14C-PXL770

Drug: 14C labeled PXL770

Interventions

14C labeled PXL770 DRUG

Single administration

Healthy volunteer

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Poxel SA: lead

Study Sites (1)

Quotient

Nottingham, United Kingdom

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2019
• First Posted: March 22, 2019
• Study Start: February 6, 2019
• Primary Completion: March 15, 2019
• Study Completion: March 15, 2019
• Last Updated: March 22, 2019

Record last verified: 2019-03

Locations

GB (1)