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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Oral capsule
Oral capsule
Teva Investigational Site 38189
Groningen, Netherlands
Cumulative Amount of Total Radioactivity (TRA)
Time frame: Up to Day 22
Cumulative Percent of TRA From the Total Radioactive Dose Administered
Time frame: Up to Day 22
Maximum Observed Plasma Concentration (Cmax)
Time frame: Up to Day 22
Time to Attain Maximum Observed Plasma Concentration (Tmax)
Time frame: Up to Day 22
Area Under the Plasma Concentration-time Curve up to 24 Hours Postdose (AUC0-24)
Time frame: 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)
Time frame: Up to Day 22
Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-∞)
Time frame: Up to Day 22
Terminal elimination half-life (t1/2)
Time frame: Up to Day 22
Number of Participants With At Least One Treatment-Emergent Adverse Event
Time frame: Up to Day 59
Number of Participants Who Did Not Complete the Trial Due to an Adverse Event
Time frame: Up to Day 59
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