Mass Balance Clinical Trial With TEV-56286

Teva Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Healthy Participants

Treatments

Drug: [14C]-TEV-56286

Drug: TEV-56286

Study type

Interventional

Funder types

Industry

Identifiers

TV56286-MB-10193

Details and patient eligibility

About

Mass balance clinical trial with TEV-56286

Full 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.

Enrollment

8 patients

Sex

Male

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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