Clinical trial NCT06627231: Mass Balance Clinical Trial With TEV-56286
Official title: A Phase 1 Open-Label Mass Balance Clinical Trial to Investigate the Absorption, Metabolism, and Excretion of Single Oral Administration of [14C]-TEV-56286 Following Multiple Oral Administrations of Nonlabeled TEV-56286 to Healthy Male Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2024-10-04
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cumulative Amount of Total Radioactivity (TRA)
timeFrame: Up to Day 22
measure: Cumulative Percent of TRA From the Total Radioactive Dose Administered
timeFrame: Up to Day 22
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Up to Day 22
measure: Time to Attain Maximum Observed Plasma Concentration (Tmax)
timeFrame: Up to Day 22
measure: Area Under the Plasma Concentration-time Curve up to 24 Hours Postdose (AUC0-24)
timeFrame: Up to Day 22
measure: 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)
timeFrame: Up to Day 22
measure: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-∞)
timeFrame: Up to Day 22
measure: Terminal elimination half-life (t1/2)
timeFrame: Up to Day 22
Secondary outcomes:
measure: Number of Participants With At Least One Treatment-Emergent Adverse Event
timeFrame: Up to Day 59
measure: Number of Participants Who Did Not Complete the Trial Due to an Adverse Event
timeFrame: Up to Day 59
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: Teva Investigational Site 38189
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Teva Medical Expert, MD
role: STUDY_DIRECTOR
References: