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

NCT04037618 | Completed Phase 1

• 1 other identifier: EYP001-106
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (1)

• Number of subjects with adverse events

  Day 1 to Day 4 or until discharge

Study Arms (1)

[14C]-EYP001a

EXPERIMENTAL

\[14C\]-EYP001a dose A containing 100 μCi radioactivity

Drug: [14C]-EYP001a

Interventions

[14C]-EYP001a DRUG

Oral drinking suspension

[14C]-EYP001a

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Enyo Pharma: lead

Study Sites (1)

QPS Netherlands B.V.

Groningen, 9713, Netherlands

Location

Study Officials

• C. Voors-Pette, MD

  QPS Netherlands B.V.

  PRINCIPAL INVESTIGATOR

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: July 26, 2019
• First Posted: July 30, 2019
• Study Start: July 24, 2019
• Primary Completion: July 27, 2019
• Study Completion: August 6, 2019
• Last Updated: September 11, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)