Healthy ParticipantsPhase 1NCT06627231
Mass Balance Clinical Trial With TEV-56286
A Phase 1 study testing TEV-56286 and [14C]-TEV-56286 in people with Healthy Participants, run by Teva Branded Pharmaceutical Products R&D, Inc. at 1 site in Netherlands.
Trial summary
Mass balance clinical trial with TEV-56286 Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- TEV-56286 and [14C]-TEV-56286
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteNetherlands
- Study dates
- 8 Oct 2024to 29 Nov 2024
- 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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- No major trauma or surgery in the 2 months before screening or at any time between screening and the first dose of the study drug, or surgery scheduled during the clinical trial including the follow-up period.
- No history of malignancy or treatment of malignancy in the last 5 years.
- No personal or family history of arrhythmia, sudden unexplained death at a young age (before 40 years) in a first-degree relative, or long QT syndrome, or a personal history of syncope of undetermined reason or previous treatment for high blood pressure.
- NOTE- Additional criteria apply, please contact the investigator for more information
Who cannot join
- History of relevant drug and/or food allergies.
- Exposure to radiation for diagnostic reasons (except dental X-rays and plain X-rays of thorax and bony skeleton [excluding spinal column]), during work, or during participation in a clinical trial in the period of 1 year prior to screening.
- NOTE- Additional criteria apply, please contact the investigator for more information
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Open-Label Mass Balance Clinical Trial to Investigate the Absorption, Metabolism, and Excretion of Single Oral Administration of [14C]-TEV-56286 Following Multiple Oral Administrations of Nonlabeled TEV-56286 to Healthy Male Participants
Mass balance clinical trial with TEV-56286
Read the detailed description
Primary objectives:
- To investigate the mass balance and excretion of TEV-56286 following a single oral dose of [14C]-TEV-56286
- To assess the pharmacokinetics following a single oral dose of [14C]-TEV-56286
Secondary objective:
- To evaluate the safety and tolerability of TEV-56286 following once daily multiple oral dose administration
The total duration of the clinical trial for each participant is expected to be approximately 59 days.
- Conditions
- Healthy Participants
- Being tested
- TEV-56286, [14C]-TEV-56286
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEV-56286Drug
Also called emrusolmin
Oral capsule
[14C]-TEV-56286Drug
Also called emrusolmin
Oral capsule
| Study group | Role | What they receive |
|---|---|---|
| TEV-56286 | Experimental | Not described Receives: Drug: TEV-56286; Drug: [14C]-TEV-56286 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Amount of Total Radioactivity (TRA)
Measured: Up to Day 22
Cumulative Percent of TRA From the Total Radioactive Dose Administered
Measured: Up to Day 22
Maximum Observed Plasma Concentration (Cmax)
Measured: Up to Day 22
Time to Attain Maximum Observed Plasma Concentration (Tmax)
Measured: Up to Day 22
Area Under the Plasma Concentration-time Curve up to 24 Hours Postdose (AUC0-24)
Measured: Up to Day 22
Area Under the Plasma Concentration-time Curve Up To Time t, Where t is the Last Point with Concentrations Above the Lower Limit of Quantification (AUC0-t)
Measured: Up to Day 22
Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-∞)
Measured: Up to Day 22
Terminal elimination half-life (t1/2)
Measured: Up to Day 22
Secondary outcomes (2)
Number of Participants With At Least One Treatment-Emergent Adverse Event
Measured: Up to Day 59
Number of Participants Who Did Not Complete the Trial Due to an Adverse Event
Measured: Up to Day 59
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start8 Oct 2024
- Primary completion29 Nov 2024
- Study completion29 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Teva Medical Expert, MD, Study director, Teva Branded Pharmaceutical Products R&D, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06627231
- Sponsor's protocol ID
- TV56286-MB-10193
- Status last verified
- Aug 2026
- First submitted
- 2 Oct 2024
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please visit www.clinicalstudydatarequest.com to make your request.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open-Label Mass Balance Clinical Trial to Investigate the Absorption, Metabolism, and Excretion of Single Oral Administration of [14C]-TEV-56286 Following Multiple Oral Administrations of Nonlabeled TEV-56286 to Healthy Male Participants
- ClinicalTrials.gov ID
- NCT06627231
- Acronym / sponsor ID
- TV56286-MB-10193
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Oct 2024 (actual)
- Primary completion
- 29 Nov 2024 (actual)
- Study completion
- 29 Nov 2024 (actual)
- First posted
- 4 Oct 2024 (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.
Mass balance clinical trial with TEV-56286
Detailed description
Primary objectives:
- To investigate the mass balance and excretion of TEV-56286 following a single oral dose of [14C]-TEV-56286
- To assess the pharmacokinetics following a single oral dose of [14C]-TEV-56286
Secondary objective:
- To evaluate the safety and tolerability of TEV-56286 following once daily multiple oral dose administration
The total duration of the clinical trial for each participant is expected to be approximately 59 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TEV-56286 | Experimental | Drug: TEV-56286, Drug: [14C]-TEV-56286 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- No major trauma or surgery in the 2 months before screening or at any time between screening and the first dose of the study drug, or surgery scheduled during the clinical trial including the follow-up period.
- No history of malignancy or treatment of malignancy in the last 5 years.
- No personal or family history of arrhythmia, sudden unexplained death at a young age (before 40 years) in a first-degree relative, or long QT syndrome, or a personal history of syncope of undetermined reason or previous treatment for high blood pressure.
- NOTE- Additional criteria apply, please contact the investigator for more information
Key exclusion criteria (3 listed)
- History of relevant drug and/or food allergies.
- Exposure to radiation for diagnostic reasons (except dental X-rays and plain X-rays of thorax and bony skeleton [excluding spinal column]), during work, or during participation in a clinical trial in the period of 1 year prior to screening.
- NOTE- Additional criteria apply, please contact the investigator for more information
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 |
|---|---|---|
| TEV-56286Also: emrusolminOral capsule | Drug | TEV-56286 |
| [14C]-TEV-56286Also: emrusolminOral capsule | Drug | TEV-56286 |
Primary outcome
Cumulative Amount of Total Radioactivity (TRA)
Time frame: Up to Day 22
Cumulative Percent of TRA From the Total Radioactive Dose Administered
Time frame: Up to Day 22
Maximum Observed Plasma Concentration (Cmax)
Time frame: Up to Day 22
Time to Attain Maximum Observed Plasma Concentration (Tmax)
Time frame: Up to Day 22
Area Under the Plasma Concentration-time Curve up to 24 Hours Postdose (AUC0-24)
Time frame: Up to Day 22
Area Under the Plasma Concentration-time Curve Up To Time t, Where t is the Last Point with Concentrations Above the Lower Limit of Quantification (AUC0-t)
Time frame: Up to Day 22
Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-∞)
Time frame: Up to Day 22
Terminal elimination half-life (t1/2)
Time frame: Up to Day 22
2 secondary outcomes
Number of Participants With At Least One Treatment-Emergent Adverse Event
Time frame: Up to Day 59
Number of Participants Who Did Not Complete the Trial Due to an Adverse Event
Time frame: Up to Day 59
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 7 Aug 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please visit www.clinicalstudydatarequest.com to make your request.
Related trials for Healthy Participants
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
RecruitingPhase 1
A Study to Evaluate the Metabolism, the Routes and Extent of Elimination, and Drug Levels of [14C]Navlimetostat (BMS-986504) in Healthy Female Participants
Healthy Female Participants
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants
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.
Teva Medical Expert, MD study director
Teva Branded Pharmaceutical Products R&D, Inc.
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 TEV-56286 and [14C]-TEV-56286 in people with Healthy Participants, run by Teva Branded Pharmaceutical Products R&D, Inc. 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 4 inclusion and 3 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 7 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 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?
Cumulative Amount of Total Radioactivity (TRA) (time frame: Up to Day 22). The study lists 8 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 7 Aug 2026.