Mass Balance Clinical Trial With TEV-56286

NCT06627231 | Completed Phase 1

• 1 other identifier: TV56286-MB-10193
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Mass balance clinical trial with TEV-56286

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (2)

• 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

Study Arms (1)

TEV-56286

EXPERIMENTAL

Drug: TEV-56286; Drug: [14C]-TEV-56286

Interventions

TEV-56286 DRUG

Oral capsule

Also known as: emrusolmin

TEV-56286

[14C]-TEV-56286 DRUG

Oral capsule

Also known as: emrusolmin

TEV-56286

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead

Study Sites (1)

Teva Investigational Site 38189

Groningen, 9728 NZ, Netherlands

Location

Study Officials

• Teva Medical Expert, MD

  Teva Branded Pharmaceutical Products R&D, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2024
• First Posted: October 4, 2024
• Study Start: October 8, 2024
• Primary Completion: November 29, 2024
• Study Completion: November 29, 2024
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)