Mass Balance Study to Investigate the Absorption, Metabolism and Excretion of [14C]-EYP001a After a Single Oral Dose

An Open-label, Mass Balance Study to Investigate the Absorption, Metabolism and Excretion of [14C]-EYP001a After a Single Oral Dose to Healthy Male Subjects

The study is designed to investigate the absorption, metabolism, and excretion of EYP001a as well as the safety/tolerability of EYP001a following the administration of a single oral dose to healthy male volunteers. The EYP001a dose is administered in a [14C]-labeled form to enable detection and quantitation of dose-related material independent of possible biotransformation.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: [14C]-EYP001a

Detailed Description

This is a single site, open-label, mass balance phase 1 study.

Six healthy male subjects will receive a single oral dose A of [14C]-EYP001a containing 100 μCi radioactivity.

• Eligibility is assessed during a screening period of up to 4 weeks.
• Subjects will check into the clinic one day prior to dosing (Day -1) for baseline assessments and to (re-)confirm eligibility.
• The study drug will be administered on Day 1, after an overnight fast of at least 10 hours.
• Blood, urine and fecal samples will be collected up to and including Day 4. If the study discharge criteria are not met on Day 4, blood, urine and fecal samples will be collected in 24- hour intervals until the study discharge criteria are met.
• An End of Study Visit will be planned at Day 14 (+/- 1 Day).

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands, 9713
    • QPS Netherlands B.V.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Able to provide informed consent to participate in this study.
• Healthy and free from clinically significant illness or disease as determined by medical history, physical examination, laboratory and other tests at Screening.
• A body weight of ≥60 kg and a body mass index ranging from 18.0 to 35.0 kg/m2 at Screening.
• Subject must agree to minimize the risk of a female partner becoming pregnant from the dosing day until 3 months after the completion of the study. Acceptable methods of contraception for male volunteers include abstinence from sexual intercourse, a vasectomy no less than 6 months prior to dosing, barrier contraception or a medically accepted contraceptive method. For female partners of male volunteers, acceptable methods of contraception include intra-uterine device (which should be placed at least 1 month before the start of the study), tubal ligation (which took place at least 6 months prior to the start of the study), hormonal contraceptive since at least two months and diaphragm with spermicide. If the subject is a sperm donor, the subject must agree not to donate sperm during the study and until 90 days after the last intake of study drug.
• In the Investigator's opinion, subject is able to understand the nature of the study and any risks involved in participation, and willing to cooperate and comply with the protocol restrictions and requirements.

Exclusion Criteria:

• Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance.
• History or current clinically significant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic, hormonal disorders.
• History of any major surgery within the last 4 weeks before participation in this study or any bone fracture within the last 2 months.
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders.
• Chronic or relevant acute infections.
• History of allergy/ hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator.
• History of any bleeding disorder including prolonged or habitual bleeding, other hematologic disease or cerebral bleeding (e.g. after a car accident) or commotion cerebri.
• Intake of drugs with a long half-life (>24 hours) within 1 month prior to study drug administration.
• Use of any kind of prescription medication from 14 days prior to the administration of the study drug.
• Use of any kind of over-the-counter products and/or natural health products (including food supplements, herbal supplements, etc.) from 7 days prior to the administration of the study drug.
• Participation in another trial with an investigational drug within 2 months prior to administration of the study drug or during the trial.
• The subject is a smoker or uses other nicotine-containing products.
• Alcohol abuse.
• History of drug abuse.
• Blood donation within 3 months prior to administration or during the trial.
• Any laboratory value outside the reference range, unless considered to lack clinical relevance.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [14C]-EYP001a; [14C]-EYP001a dose A containing 100 μCi radioactivity	Drug: [14C]-EYP001a; Oral drinking suspension

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radioactivity-time profiles in whole blood and plasma		Day 1 to Day 4 or until discharge
Cmax	Maximum observed total radioactivity in plasma and whole blood	Day 1 to Day 4 or until discharge
tmax	Time from dosing to peak total radioactivity in plasma and whole blood	Day 1 to Day 4 or until discharge
AUC0-24	Area under the total radioactivity-time curve in plasma and whole blood from time zero to 24 hours	0 to 24 hours
[14C]-metabolic profile and identification of metabolites in plasma		Day 1 to Day 4 or until discharge
[14C]-radioactivity in urine		Day 1 to Day 4 or until discharge
[14C]-metabolic profile and identification of metabolites in urine		Day 1 to Day 4 or until discharge
[14C]-radioactivity in feces		Day 1 to Day 4 or until discharge
[14C]-metabolic profile and identification of metabolites in feces		Day 1 to Day 4 or until discharge

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of subjects with adverse events	Day 1 to Day 4 or until discharge

Collaborators and Investigators

• Sponsor: Enyo Pharma
• Investigators: Principal Investigator: C. Voors-Pette, MD, QPS Netherlands B.V.

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2019
• Primary Completion (Actual): July 27, 2019
• Study Completion (Actual): August 6, 2019

Study Registration Dates

• First Submitted: July 26, 2019
• First Submitted That Met QC Criteria: July 26, 2019
• First Posted (Actual): July 30, 2019

Study Record Updates

• Last Update Posted (Actual): September 11, 2019
• Last Update Submitted That Met QC Criteria: September 10, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: EYP001-106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No