HealthyPhase 1NCT04037618
Mass Balance Study to Investigate the Absorption, Metabolism and Excretion of [14C]-EYP001a After a Single Oral Dose
A Phase 1 study testing [14C]-EYP001a in people with Healthy, run by Enyo Pharma at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- [14C]-EYP001a
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteNetherlands
- Study dates
- 24 Jul 2019to 6 Aug 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Healthy
- Being tested
- [14C]-EYP001a
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]-EYP001aDrug
Oral drinking suspension
| Study group | Role | What they receive |
|---|---|---|
| [14C]-EYP001a | Experimental | [14C]-EYP001a dose A containing 100 μCi radioactivity Receives: Drug: [14C]-EYP001a |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radioactivity-time profiles in whole blood and plasma
Measured: Day 1 to Day 4 or until discharge
Cmax
Maximum observed total radioactivity in plasma and whole blood
Measured: Day 1 to Day 4 or until discharge
tmax
Time from dosing to peak total radioactivity in plasma and whole blood
Measured: 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
Measured: 0 to 24 hours
[14C]-metabolic profile and identification of metabolites in plasma
Measured: Day 1 to Day 4 or until discharge
[14C]-radioactivity in urine
Measured: Day 1 to Day 4 or until discharge
[14C]-metabolic profile and identification of metabolites in urine
Measured: Day 1 to Day 4 or until discharge
[14C]-radioactivity in feces
Measured: Day 1 to Day 4 or until discharge
[14C]-metabolic profile and identification of metabolites in feces
Measured: Day 1 to Day 4 or until discharge
Secondary outcomes (1)
Number of subjects with adverse events
Measured: Day 1 to Day 4 or until discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start24 Jul 2019
- Primary completion27 Jul 2019
- Study completion6 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enyo Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- C. Voors-Pette, MD, Principal investigator, QPS Netherlands B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04037618
- Sponsor's protocol ID
- EYP001-106
- Status last verified
- Sep 2019
- First submitted
- 26 Jul 2019
- Last updated
- 11 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04037618
- Acronym / sponsor ID
- EYP001-106
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Enyo PharmaIndustry (pharma, biotech, devices)
- Study start
- 24 Jul 2019 (actual)
- Primary completion
- 27 Jul 2019 (actual)
- Study completion
- 6 Aug 2019 (actual)
- First posted
- 30 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C]-EYP001a | Experimental | Drug: [14C]-EYP001a[14C]-EYP001a dose A containing 100 μCi radioactivity |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [14C]-EYP001aOral drinking suspension | Drug | [14C]-EYP001a |
Primary outcome
Radioactivity-time profiles in whole blood and plasma
Time frame: Day 1 to Day 4 or until discharge
Cmax
Time frame: Day 1 to Day 4 or until discharge
Maximum observed total radioactivity in plasma and whole blood
tmax
Time frame: Day 1 to Day 4 or until discharge
Time from dosing to peak total radioactivity in plasma and whole blood
AUC0-24
Time frame: 0 to 24 hours
Area under the total radioactivity-time curve in plasma and whole blood from time zero to 24 hours
[14C]-metabolic profile and identification of metabolites in plasma
Time frame: Day 1 to Day 4 or until discharge
[14C]-radioactivity in urine
Time frame: Day 1 to Day 4 or until discharge
[14C]-metabolic profile and identification of metabolites in urine
Time frame: Day 1 to Day 4 or until discharge
[14C]-radioactivity in feces
Time frame: Day 1 to Day 4 or until discharge
[14C]-metabolic profile and identification of metabolites in feces
Time frame: Day 1 to Day 4 or until discharge
1 secondary outcome
Number of subjects with adverse events
Time frame: Day 1 to Day 4 or until discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
C. Voors-Pette, MD principal investigator
QPS Netherlands B.V.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [14C]-EYP001a in people with Healthy, run by Enyo Pharma at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radioactivity-time profiles in whole blood and plasma (time frame: Day 1 to Day 4 or until discharge). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2019.