CompletedPhase 1

Mass Balance Clinical Trial With TEV-56286

Netherlands8 participantsStarted 2024-10-08

Plain-language summary

Mass balance clinical trial with TEV-56286

Who can participate

Age range

18 Years – 65 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cumulative Amount of Total Radioactivity (TRA)

Timeframe: Up to Day 22

Cumulative Percent of TRA From the Total Radioactive Dose Administered

Timeframe: Up to Day 22

Maximum Observed Plasma Concentration (Cmax)

Timeframe: Up to Day 22

Time to Attain Maximum Observed Plasma Concentration (Tmax)

Timeframe: Up to Day 22

Area Under the Plasma Concentration-time Curve up to 24 Hours Postdose (AUC0-24)

Timeframe: 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)

Timeframe: Up to Day 22

Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-∞)

Timeframe: Up to Day 22

Trial details

NCT IDNCT06627231

SponsorTeva Branded Pharmaceutical Products R&D, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-11-29

View on ClinicalTrials.gov More Healthy Participants trials

Who can participate

Age range

18 Years – 65 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Cumulative Amount of Total Radioactivity (TRA)

Timeframe: Up to Day 22

Cumulative Percent of TRA From the Total Radioactive Dose Administered

Timeframe: Up to Day 22

Maximum Observed Plasma Concentration (Cmax)

Timeframe: Up to Day 22

Time to Attain Maximum Observed Plasma Concentration (Tmax)

Timeframe: Up to Day 22

Area Under the Plasma Concentration-time Curve up to 24 Hours Postdose (AUC0-24)

Timeframe: 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)

Timeframe: Up to Day 22

Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-∞)

Timeframe: Up to Day 22