Mass Balance Clinical Trial With TEV-56286

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

Mass balance clinical trial with TEV-56286

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: TEV-56286; Drug: [14C]-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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands, 9728 NZ
    • Teva Investigational Site 38189

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TEV-56286	Drug: TEV-56286; Oral capsule; Other Names: emrusolmin; Drug: [14C]-TEV-56286; Oral capsule; Other Names: emrusolmin

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
• Investigators: Study Director: Teva Medical Expert, MD, Teva Branded Pharmaceutical Products R&D, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2024
• Primary Completion (Actual): November 29, 2024
• Study Completion (Actual): November 29, 2024

Study Registration Dates

• First Submitted: October 2, 2024
• First Submitted That Met QC Criteria: October 2, 2024
• First Posted (Actual): October 4, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 28, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: TV56286-MB-10193

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please visit www.clinicalstudydatarequest.com to make your request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No