Healthy Participants
Conditions
Brief summary
Mass balance clinical trial with TEV-56286
Detailed 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.
Interventions
DRUGTEV-56286
Oral capsule
DRUG[14C]-TEV-56286
Oral capsule
Sponsors
Teva Branded Pharmaceutical Products R&D, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative Amount of Total Radioactivity (TRA) | Up to Day 22 |
| Cumulative Percent of TRA From the Total Radioactive Dose Administered | Up to Day 22 |
| Maximum Observed Plasma Concentration (Cmax) | Up to Day 22 |
| Time to Attain Maximum Observed Plasma Concentration (Tmax) | Up to Day 22 |
| Area Under the Plasma Concentration-time Curve up to 24 Hours Postdose (AUC0-24) | 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) | Up to Day 22 |
| Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-∞) | Up to Day 22 |
| Terminal elimination half-life (t1/2) | Up to Day 22 |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With At Least One Treatment-Emergent Adverse Event | Up to Day 59 |
| Number of Participants Who Did Not Complete the Trial Due to an Adverse Event | Up to Day 59 |
Countries
Netherlands
Contacts
STUDY_DIRECTORTeva Medical Expert, MD
Teva Branded Pharmaceutical Products R&D, Inc.
Outcome results
None listed