NCT03886103CompletedPhase 1
Pharmacokinetics and Metabolism of [14C]-Labelled PXL770 Following a Single Oral Administration in Healthy Male Volunteers
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Poxel SA
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Mass balance recovery
Study Overview
Brief Summary
This is a single-dose, single center, single-period, open-label, non-randomized, mass balance recovery study in healthy male subjects.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to 65 Years (Adult, Older Adult)
- Sex
- 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
- •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
Arms & Interventions
Healthy volunteer
Experimental
Single of 14C-PXL770
Intervention: 14C labeled PXL770 (Drug)
Outcomes
Primary Outcomes
Mass balance recovery
Time Frame: From day 1 to day 7
Mass balance recovery of total radioactivity in all excreta: cumulative recovery (CumAe) and cumulative recovery expressed as a percentage of the dose (Cum%Ae)
Secondary Outcomes
- PK profile of PXL770(From day 1 to day 7)
- PK profile of total radioactivity(From day 1 to day 7)
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](From day 1 to day 7)
Investigators
Study Sites (1)
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