A Phase 1 interventional study of TEV-56286 and [14C]-TEV-56286 in Healthy Participants, sponsored by Teva Branded Pharmaceutical Products R&D, Inc.. Completed at 1 site in Netherlands. Open to male participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-07.
Sponsored by Teva Branded Pharmaceutical Products R&D, Inc. (part of Teva Pharmaceutical Industries, Ltd.) · Phase 1, Interventional, and Treatment
Mass balance clinical trial with TEV-56286
Primary objectives:
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.
Teva Branded Pharmaceutical Products R&D, Inc. is the lead sponsor of 206 studies on the registry; none are open to participants now.
Of its 49 completed or terminated interventional studies of FDA-regulated products, 47 (96%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
NOTE- Additional criteria apply, please contact the investigator for more information
Exclusion Criteria:
NOTE- Additional criteria apply, please contact the investigator for more information
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: TEV-56286 · Drug: [14C]-TEV-56286
Oral capsule
Also known as: emrusolmin
Oral capsule
Also known as: emrusolmin
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
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
Plan to share: 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.
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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