Mass Balance Clinical Trial With TEV-56286
- Registration Number
- NCT06627231
- Lead Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 8
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TEV-56286 TEV-56286 - TEV-56286 [14C]-TEV-56286 -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Teva Investigational Site 38189
🇳🇱Groningen, Netherlands