Healthy VolunteersPhase 1NCT07308236
A Study to Determine the Metabolism and Excretion of [14C]E2086 in Healthy Male Participants
A Phase 1 study testing E2086 in people with Healthy Volunteers, run by Eisai Inc. at 1 site in United States.
Trial summary
The primary purpose of this study is to determine the metabolism and excretion of [14C]E2086 in healthy male participants. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- E2086
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Dec 2025to 12 Jun 2026
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-smoking and non-vaping, healthy male, age greater than or equal to (>=) 18 years and less than or equal to (<=) 55 years old at the time of informed consent
- Body Mass Index (BMI) >=18 and less than (<) 30 kilogram per square meter (kg/m^2) at Screening
- Provide written informed consent
- Willing and able to comply with all aspects of the protocol
Who cannot join
- Have previously been dosed in more than 2 radiolabeled drug studies in the past 12 months. For participants who have previously been dosed in 2 or more radiolabeled drug studies within the last 12 months, the previous radiolabeled dose must be at least 4 months prior to check-in to the trial site where exposures are known to the investigator, or 6 months prior to check-in to the trial site for a radiolabeled drug trial where exposures are not known to the investigator. The total 12-month exposure from this trial and a maximum of 2 other previous radiolabeled studies must be within the CFR recommended levels considered safe, per US Title 21 CFR 361.1.
- Exposure to significant diagnostic or therapeutic radiation (eg, serial x-ray, computed tomography scan, barium meal) or current employment in a job requiring radiation exposure monitoring within 12 months prior to check-in.
- Males who have not had a successful vasectomy (confirmed azoospermia) or they and their female partners must meet the following criteria: not of childbearing potential or practicing highly effective contraception throughout the trial period and for 28 days after trial drug discontinuation. No sperm donation is allowed during the trial period and for 90 days after trial drug discontinuation.
- NOTE: All female partners of male participants will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (ie, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing). Examples of highly effective contraception include total abstinence, an intrauterine device, a double-barrier method (such as condom plus diaphragm with spermicide), a contraceptive implant, and oral contraceptive. Female partners of male participants who have not had a successful vasectomy, who use hormonal contraception, must be on the same hormonal contraceptive for 28 days before the male participants are dosed with trial drug, throughout the trial period and for 28 days afterwards.
- Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks of dosing.
- Evidence of disease that may influence the outcome of the trial within 4 weeks before dosing, eg, psychiatric disorders and disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, or cardiovascular system.
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- Any history of surgery that may affect PK profiles of E2086 (eg, hepatectomy, nephrectomy, digestive organ resection) or participants who have a congenital abnormality in metabolism at Screening.
- Any clinically abnormal symptom or organ impairment found by medical history at Screening, including estimated glomerular filtration rate (eGFR) <90 mL/min), and physical examinations, vital signs, electrocardiogram (ECG) findings, or laboratory test results that require medical treatment at Screening or Baseline.
- Initiation of statin therapy, or a change to a different statin, or an increase in the dose of a statin within the 6 months before the planned start of the study
- A prolonged QT/QTc interval (QTcF greater than (>) 450 millisecond [ms]) as demonstrated by the mean of triplicate ECGs (recorded at least 1 min apart) at Screening or Baseline
- Systolic blood pressure >140 millimeter of mercury (mmHg) or diastolic blood pressure >90 mmHg at Screening or Baseline
- Heart rate <50 beats/min or >100 beats/min at Screening or Baseline
- Any lifetime history of suicidal ideation or any lifetime history of suicidal behavior as indicated by the Columbia-Suicide Severity Rating Scale (C-SSRS).
- Any lifetime history of psychiatric disease (including, but not limited to, depression or other mood disorders, bipolar disorder, psychotic disorders, including schizophrenia, panic attacks, and anxiety disorders [if ever treated with medication]).
- Known history of clinically significant drug allergy at Screening or Baseline
- Known history of food allergies or presently experiencing significant seasonal or perennial allergy at Screening or Baseline.
- Known to be human immunodeficiency virus (HIV) positive at Screening
- History of drug or alcohol dependency or abuse within the 2 years before Screening, or those who have a positive urine drug test or alcohol test at Screening or Baseline.
- Currently enrolled in another clinical trial or used any investigational drug or device within 30 days (or 5 half-lives, whichever is longer) preceding informed consent
- Use of illegal recreational drugs and marijuana
- Receipt of blood products within 4 weeks, or donation of blood within 8 weeks, or donation of plasma within 1 week before dosing.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fortrea Clinical Research Unit Inc.
Madison, Wisconsin, 53704
About this study
Official title: An Open-Label, Single Dose Study to Determine the Metabolism and Excretion of [14C]E2086 in Healthy Male Subjects
The primary purpose of this study is to determine the metabolism and excretion of [14C]E2086 in healthy male participants.
- Conditions
- Healthy Volunteers
- Being tested
- E2086
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E2086Drug
E2086 oral capsule.
| Study group | Role | What they receive |
|---|---|---|
| E2086 | Experimental | Not described Receives: Drug: E2086 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mass Balance Recovery of E2086, Expressed as Cumulative Percent of the Radiolabeled Dose
Mass balance will be determined by pharmacokinetic (PK) analysis of [14C]E2086 and E2086 in the biological matrices.
Measured: Day 1 up to Day 21
Maximum Observed Concentration (Cmax) of [14C]E2086 for Total Radioactivity (TRA) in Plasma
Measured: Day 1 up to Day 21
Time to Reach Cmax (Tmax) of [14C]E2086 for TRA in Plasma
Measured: Day 1 up to Day 21
Area Under the Concentration-time Curve from Zero Time to Time of Last Quantifiable Concentration [AUC (0-t)] of [14C]E2086 for TRA in Plasma
Measured: Day 1 up to Day 21
Area Under the Concentration-time Curve from Zero Time Extrapolated to Infinite Time [AUC (0-inf)] of [14C]E2086 for TRA in Plasma
Measured: Day 1 up to Day 21
Terminal Elimination Phase Half-life (t1/2) of [14C]E2086 for TRA in Plasma
Measured: Day 1 up to Day 21
Cmax of [14C]E2086 for TRA in Whole Blood
Measured: Day 1 up to Day 21
Tmax of [14C]E2086 for TRA in Whole Blood
Measured: Day 1 up to Day 21
AUC (0-t) of [14C]E2086 for TRA in Whole Blood
Measured: Day 1 up to Day 21
AUC (0-inf) of [14C]E2086 for TRA in Whole Blood
Measured: Day 1 up to Day 21
t1/2 of [14C]E2086 for TRA in Whole Blood
Measured: Day 1 up to Day 21
Cmax of E2086 and its Metabolite M1 in Plasma Using liquid Chromatography Coupled With Mass Spectrometry (LC-MS/MS)
Measured: Day 1 up to Day 21
Tmax E2086 and its Metabolite M1 in Plasma Using LC-MS/MS
Measured: Day 1 up to Day 21
AUC (0-t) of E2086 and its Metabolite M1 in Plasma Using LC-MS/MS
Measured: Day 1 up to Day 21
AUC (0-inf) of E2086 and its Metabolite M1 in Plasma Using LC-MS/MS
Measured: Day 1 up to Day 21
t1/2 of E2086 and its Metabolite M1 in Plasma Using LC-MS/MS
Measured: Day 1 up to Day 21
Apparent Total Clearance (CL/F) of E2086 in Plasma Using LC-MS/MS
Measured: Day 1 up to Day 21
Apparent Volume of Distribution (Vz/F) at Terminal Phase of E2086 in Plasma Using LC-MS/MS
Measured: Day 1 up to Day 21
Metabolite Ratio (MRp) of E2086 and its Metabolite M1 in Plasma Using LC-MS/MS
Measured: Day 1 up to Day 21
Cumulative Amount Excreted in Urine from Zero Time to Time of Last Interval (Ae) of E2086 and its Metabolite M1 in Urine Using LC-MS/MS
Measured: Day 1 up to Day 21
Fraction of Dose Excreted in Urine from Zero Time to Time of Last Interval (Fe) of E2086 and its Metabolite M1 in Urine Using LC-MS/MS
Measured: Day 1 up to Day 21
Renal Clearance (CLR) of E2086 and its Metabolite M1 in Urine Using LC-MS/MS
Measured: Day 1 up to Day 21
MRu of E2086 and its Metabolite M1 in Urine Using LC-MS/MS
Measured: Day 1 up to Day 21
Percentage of Administered Radioactive Dose Excreted in Urine, Feces, and Toilet Tissue by TRA
Measured: Day 1 up to Day 21
Secondary outcomes (5)
Characterization of Metabolites in Plasma, Urine, Feces After Administration of a Single Oral Dose of Radiolabeled [14C]E2086
Metabolite profiling in plasma, urine, and feces will be performed by radio-high performance liquid chromatography (HPLC) methods and/or accelerator mass spectrometry. Metabolites (M1) and other metabolites will be identified and estimated on the radiochromatograms, and the amount of each metabolite will be quantified based on the peak areas on the radiochromatograms. For metabolites detected on the radiochromatograms, LC-MS/MS analysis may be performed to estimate and identify their chemical structures.
Measured: Up to 21 days
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Measured: Up to 21 days
Number of Participants With Abnormal Laboratory Parameter Values
Measured: Up to 21 days
Number of Participants With Clinically Significant Change in Vital Sign Values
Measured: Up to 21 days
Number of Participants With Clinically Significant Change in 12-Lead Electrocardiogram (ECG) Values
Measured: Up to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start31 Dec 2025
- Primary completion12 Jun 2026
- Study completion12 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Eisai Inc.The sponsor's other registered studies.
- 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07308236
- Sponsor's protocol ID
- E2086-A001-004
- Status last verified
- Aug 2026
- First submitted
- 15 Dec 2025
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single Dose Study to Determine the Metabolism and Excretion of [14C]E2086 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT07308236
- Acronym / sponsor ID
- E2086-A001-004
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Dec 2025 (actual)
- Primary completion
- 12 Jun 2026 (actual)
- Study completion
- 12 Jun 2026 (actual)
- First posted
- 29 Dec 2025 (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 primary purpose of this study is to determine the metabolism and excretion of [14C]E2086 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 |
|---|---|---|
| E2086 | Experimental | Drug: E2086 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Non-smoking and non-vaping, healthy male, age greater than or equal to (>=) 18 years and less than or equal to (<=) 55 years old at the time of informed consent
- Body Mass Index (BMI) >=18 and less than (<) 30 kilogram per square meter (kg/m^2) at Screening
- Provide written informed consent
- Willing and able to comply with all aspects of the protocol
Key exclusion criteria (21 listed)
- Have previously been dosed in more than 2 radiolabeled drug studies in the past 12 months. For participants who have previously been dosed in 2 or more radiolabeled drug studies within the last 12 months, the previous radiolabeled dose must be at least 4 months prior to check-in to the trial site where exposures are known to the investigator, or 6 months prior to check-in to the trial site for a radiolabeled drug trial where exposures are not known to the investigator. The total 12-month exposure from this trial and a maximum of 2 other previous radiolabeled studies must be within the CFR recommended levels considered safe, per US Title 21 CFR 361.1.
- Exposure to significant diagnostic or therapeutic radiation (eg, serial x-ray, computed tomography scan, barium meal) or current employment in a job requiring radiation exposure monitoring within 12 months prior to check-in.
- Males who have not had a successful vasectomy (confirmed azoospermia) or they and their female partners must meet the following criteria: not of childbearing potential or practicing highly effective contraception throughout the trial period and for 28 days after trial drug discontinuation. No sperm donation is allowed during the trial period and for 90 days after trial drug discontinuation.
- NOTE: All female partners of male participants will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (ie, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing). Examples of highly effective contraception include total abstinence, an intrauterine device, a double-barrier method (such as condom plus diaphragm with spermicide), a contraceptive implant, and oral contraceptive. Female partners of male participants who have not had a successful vasectomy, who use hormonal contraception, must be on the same hormonal contraceptive for 28 days before the male participants are dosed with trial drug, throughout the trial period and for 28 days afterwards.
- Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks of dosing.
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 |
|---|---|---|
| E2086E2086 oral capsule. | Drug | E2086 |
Primary outcome
Mass Balance Recovery of E2086, Expressed as Cumulative Percent of the Radiolabeled Dose
Time frame: Day 1 up to Day 21
Mass balance will be determined by pharmacokinetic (PK) analysis of [14C]E2086 and E2086 in the biological matrices.
Maximum Observed Concentration (Cmax) of [14C]E2086 for Total Radioactivity (TRA) in Plasma
Time frame: Day 1 up to Day 21
Time to Reach Cmax (Tmax) of [14C]E2086 for TRA in Plasma
Time frame: Day 1 up to Day 21
Area Under the Concentration-time Curve from Zero Time to Time of Last Quantifiable Concentration [AUC (0-t)] of [14C]E2086 for TRA in Plasma
Time frame: Day 1 up to Day 21
Area Under the Concentration-time Curve from Zero Time Extrapolated to Infinite Time [AUC (0-inf)] of [14C]E2086 for TRA in Plasma
Time frame: Day 1 up to Day 21
Terminal Elimination Phase Half-life (t1/2) of [14C]E2086 for TRA in Plasma
Time frame: Day 1 up to Day 21
Cmax of [14C]E2086 for TRA in Whole Blood
Time frame: Day 1 up to Day 21
Tmax of [14C]E2086 for TRA in Whole Blood
Time frame: Day 1 up to Day 21
AUC (0-t) of [14C]E2086 for TRA in Whole Blood
Time frame: Day 1 up to Day 21
AUC (0-inf) of [14C]E2086 for TRA in Whole Blood
Time frame: Day 1 up to Day 21
t1/2 of [14C]E2086 for TRA in Whole Blood
Time frame: Day 1 up to Day 21
Cmax of E2086 and its Metabolite M1 in Plasma Using liquid Chromatography Coupled With Mass Spectrometry (LC-MS/MS)
Time frame: Day 1 up to Day 21
Tmax E2086 and its Metabolite M1 in Plasma Using LC-MS/MS
Time frame: Day 1 up to Day 21
AUC (0-t) of E2086 and its Metabolite M1 in Plasma Using LC-MS/MS
Time frame: Day 1 up to Day 21
AUC (0-inf) of E2086 and its Metabolite M1 in Plasma Using LC-MS/MS
Time frame: Day 1 up to Day 21
t1/2 of E2086 and its Metabolite M1 in Plasma Using LC-MS/MS
Time frame: Day 1 up to Day 21
Apparent Total Clearance (CL/F) of E2086 in Plasma Using LC-MS/MS
Time frame: Day 1 up to Day 21
Apparent Volume of Distribution (Vz/F) at Terminal Phase of E2086 in Plasma Using LC-MS/MS
Time frame: Day 1 up to Day 21
Metabolite Ratio (MRp) of E2086 and its Metabolite M1 in Plasma Using LC-MS/MS
Time frame: Day 1 up to Day 21
Cumulative Amount Excreted in Urine from Zero Time to Time of Last Interval (Ae) of E2086 and its Metabolite M1 in Urine Using LC-MS/MS
Time frame: Day 1 up to Day 21
Fraction of Dose Excreted in Urine from Zero Time to Time of Last Interval (Fe) of E2086 and its Metabolite M1 in Urine Using LC-MS/MS
Time frame: Day 1 up to Day 21
Renal Clearance (CLR) of E2086 and its Metabolite M1 in Urine Using LC-MS/MS
Time frame: Day 1 up to Day 21
MRu of E2086 and its Metabolite M1 in Urine Using LC-MS/MS
Time frame: Day 1 up to Day 21
Percentage of Administered Radioactive Dose Excreted in Urine, Feces, and Toilet Tissue by TRA
Time frame: Day 1 up to Day 21
5 secondary outcomes
Characterization of Metabolites in Plasma, Urine, Feces After Administration of a Single Oral Dose of Radiolabeled [14C]E2086
Time frame: Up to 21 days
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Up to 21 days
Number of Participants With Abnormal Laboratory Parameter Values
Time frame: Up to 21 days
Number of Participants With Clinically Significant Change in Vital Sign Values
Time frame: Up to 21 days
Number of Participants With Clinically Significant Change in 12-Lead Electrocardiogram (ECG) Values
Time frame: Up to 21 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 21 Aug 2026.
- Individual participant dataSharing planned: Yes. Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.
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Screening Protocol
Pain
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 E2086 in people with Healthy Volunteers, run by Eisai Inc. at 1 site in United States.
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 4 inclusion and 21 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 21 Aug 2026. 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 States. 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?
Mass Balance Recovery of E2086, Expressed as Cumulative Percent of the Radiolabeled Dose (time frame: Day 1 up to Day 21). The study lists 24 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 21 Aug 2026.