Status:
COMPLETED
Mass Balance Study to Investigate the Absorption, Metabolism and Excretion of [14C]-EYP001a After a Single Oral Dose
Lead Sponsor:
Enyo Pharma
Conditions:
Healthy
Eligibility:
MALE
18-60 years
Phase:
PHASE1
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 ma...
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 asses...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 6 2019
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04037618
Start Date
July 24 2019
End Date
August 6 2019
Last Update
September 11 2019
Active Locations (1)
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1
QPS Netherlands B.V.
Groningen, Netherlands, 9713