Tracking a new Drug's journey through the body
NCT ID NCT06627231
First seen Aug 07, 2026 · Last updated Aug 07, 2026
Summary
This early-stage trial aims to understand how the body absorbs, breaks down, and eliminates an experimental drug called TEV-56286 (emrusolmin). Eight healthy men will take the drug by mouth, including a version with a radioactive label that lets researchers trace its path. The study measures how much of the drug reaches the blood, how long it stays, and how it leaves the body. It also checks for any side effects. This is a first step in drug development, not a test of whether the drug treats a disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- TEV-56286 (emrusolmin), given as an oral capsule, including a radiolabeled version to track its path through the body
- What this could lead to
- If successful, this trial will clarify how TEV-56286 is processed and cleared by the body, which is a key step toward developing it as a treatment.
- What could go wrong
- This is a very early, small study in healthy volunteers, not patients. It focuses on drug handling, not on whether the drug works for any disease, and results may not predict effects in patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
8 people
The number who actually took part.
- Started
-
Oct 2024
- Finished
-
Nov 2024
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
-
Male participants only
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * 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
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Teva Investigational Site 38189
Groningen, 9728 NZ, Netherlands
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