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CompletedNCT03886103Updated Mar 22, 2019

Pharmacokinetics and Metabolism of (14C)-Labelled PXL770

A Phase 1 interventional study of 14C labeled PXL770 in Healthy, sponsored by Poxel SA. Completed at 1 site in United Kingdom. Open to male participants aged 30 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-22.

Sponsored by Poxel SA · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Ages
30 Years to 65 Years
Sex
Male
01

Study summary

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

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Poxel SA is the lead sponsor of 14 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 65 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    Healthy volunteer

    Single of 14C-PXL770

    Drug: 14C labeled PXL770

Interventions

  • Drug14C labeled PXL770

    Single administration

06

What researchers measure

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)

    Time frame: From day 1 to day 7

Secondary outcomes

  1. PK profile of total radioactivity

    Cmax

    Time frame: From day 1 to day 7

  2. PK profile of PXL770

    Cmax

    Time frame: From day 1 to day 7

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

    Incidence of Treatment-Emergent Adverse Events

    Time frame: From day 1 to day 7

07

Study locations

1 site
  • Quotient
    Nottingham, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 22, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03886103
Lead sponsor
Poxel SA
Responsible party
Sponsor
First posted
Mar 22, 2019
Start date
Feb 6, 2019
Primary completion
Mar 15, 2019
Completion
Mar 15, 2019
Last update
Mar 22, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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