Healthy Male ParticipantsPhase 1NCT03444818
A Study to Determine the Absorption, Metabolism, and Excretion of [14C]-E6007 After a Single Oral Administration in Healthy Male Participants
A Phase 1 study testing [14C]-E6007 in people with Healthy Male Participants, run by EA Pharma Co., Ltd. at 1 site in United Kingdom.
Trial summary
This study will be conducted to evaluate the absorption, metabolism, and excretion of a single oral dose of [14C]-E6007 in healthy male participants. Read more about this study
- Who is it for?
- Ages 30 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Male Participants
- What is being tested?
- [14C]-E6007
- 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 siteUnited Kingdom
- Study dates
- 17 Apr 2018to 26 Jun 2018
- 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 30 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 30 to 55 years of age
- Body mass index between 18.5 and 30.0 kilograms per meters squared (kg/m^2), and a total body weight between 50 and 100 kilograms (kg)
- In good health, determined by no clinically significant findings from medical history, physical examination, 12 lead electrocardiogram, vital sign measurements, and clinical laboratory evaluations
- Males will agree to use contraception
- Able to comprehend and willing to sign an informed consent form and to abide by the study restrictions
Who cannot join
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, haematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy, and hernia repair will be allowed)
- Significant history or clinical manifestation of hemorrhoids
- History of alcoholism or drug/chemical abuse within 2 years prior to Check-in
- Positive hepatitis panel and/or positive human immunodeficiency virus test
Show all 14Show fewer
- Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 90 days prior to Check-in
- Use or intend to use any prescription medications/products within 14 days prior to Check-in
- Participants in receipt of a live vaccine within 30 days prior to the first dose administration or who plan to receive a live vaccine during the study and for 14 days after the dose of study drug
- Use of tobacco or nicotine containing products within 3 months prior to Check-in
- Receipt of blood products within 2 months prior to Check-in
- Donation of blood from 3 months prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening
- Participants with exposure to significant diagnostic or therapeutic radiation or current employment in a job requiring radiation exposure monitoring within 12 months prior to Check-in
- Participants who have participated in any clinical trial involving a radiolabelled investigational product within 12 months prior to Check-in
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Covance Clinical Research Unit (CRU) Ltd.
Leeds, West Yorkshire
About this study
Official title: A Phase I, Open-label, Study to Determine the Absorption, Metabolism, and Excretion of [14C]-E6007 After a Single Oral Administration in Healthy Male Subjects
This study will be conducted to evaluate the absorption, metabolism, and excretion of a single oral dose of [14C]-E6007 in healthy male participants.
- Conditions
- Healthy Male Participants
- Being tested
- [14C]-E6007
- Keywords
- E6007, Pharmacokinetics, Radioactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]-E6007Drug
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| [14C]-E6007 | Experimental | Participants will receive a single oral dose of 60 milligrams (mg) of [14C]-E6007. Receives: Drug: [14C]-E6007 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum concentration (Cmax) of E6007 derived from whole blood
Measured: Predose and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours postdose
Area under the concentration-time curve (AUC) from time zero to infinity (AUC[0-∞]) postdose of E6007
Measured: Predose and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours postdose
Total radioactivity derived from whole blood
Measured: Up to 11 days
Total radioactivity in urine
Measured: Up to 11 days
Total radioactivity in feces
Measured: Up to 11 days
Secondary outcomes (2)
Number of participants with any serious adverse event
Measured: Up to 11 days
Number of participants with any non-serious adverse event
Measured: Up to 11 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study start17 Apr 2018
- Primary completion26 Jun 2018
- Study completion26 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Male ParticipantsStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- EA Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03444818
- Sponsor's protocol ID
- E6007-CP3
- Other IDs
- 2017-004119-38, 2017
- Status last verified
- Feb 2018
- First submitted
- 19 Feb 2018
- Last updated
- 29 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Study to Determine the Absorption, Metabolism, and Excretion of [14C]-E6007 After a Single Oral Administration in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT03444818
- Acronym / sponsor ID
- E6007-CP3
- Conditions
- Healthy Male Participants
- Keywords
- E6007, Pharmacokinetics, Radioactivity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- EA Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Apr 2018 (actual)
- Primary completion
- 26 Jun 2018 (actual)
- Study completion
- 26 Jun 2018 (actual)
- First posted
- 23 Feb 2018 (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.
This study will be conducted to evaluate the absorption, metabolism, and excretion of a single oral dose of [14C]-E6007 in healthy male participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C]-E6007 | Experimental | Drug: [14C]-E6007Participants will receive a single oral dose of 60 milligrams (mg) of [14C]-E6007. |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 30 to 55 years of age
- Body mass index between 18.5 and 30.0 kilograms per meters squared (kg/m^2), and a total body weight between 50 and 100 kilograms (kg)
- In good health, determined by no clinically significant findings from medical history, physical examination, 12 lead electrocardiogram, vital sign measurements, and clinical laboratory evaluations
- Males will agree to use contraception
- Able to comprehend and willing to sign an informed consent form and to abide by the study restrictions
Key exclusion criteria (14 listed)
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, haematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy, and hernia repair will be allowed)
- Significant history or clinical manifestation of hemorrhoids
- History of alcoholism or drug/chemical abuse within 2 years prior to Check-in
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]-E6007Oral administration | Drug | [14C]-E6007 |
Primary outcome
Maximum concentration (Cmax) of E6007 derived from whole blood
Time frame: Predose and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours postdose
Area under the concentration-time curve (AUC) from time zero to infinity (AUC[0-∞]) postdose of E6007
Time frame: Predose and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours postdose
Total radioactivity derived from whole blood
Time frame: Up to 11 days
Total radioactivity in urine
Time frame: Up to 11 days
Total radioactivity in feces
Time frame: Up to 11 days
2 secondary outcomes
Number of participants with any serious adverse event
Time frame: Up to 11 days
Number of participants with any non-serious adverse event
Time frame: Up to 11 days
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 29 Aug 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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]-E6007 in people with Healthy Male Participants, run by EA Pharma Co., Ltd. at 1 site in United Kingdom.
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 14 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 29 Aug 2018. 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 United Kingdom. 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?
Maximum concentration (Cmax) of E6007 derived from whole blood (time frame: Predose and 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72 and 96 hours postdose). The study lists 5 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 29 Aug 2018.