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