Mass balance clinical trial with TEV-56286

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.

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

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.