A Study to Assess New Formulations of TEV-56286

An Open-Label, Randomized, Crossover Study to Assess the Comparative Bioavailability of New TEV-56286 Formulations Compared to a Reference TEV-56286 Capsule Formulation Following Single-Dose Administration in Healthy Participants

The primary objective of the study is to assess the relative bioavailability of TEV-56286 test formulations compared to TEV-56286 reference product in healthy adult participants.

The secondary objective is to evaluate the safety and tolerability of TEV-56286.

The planned duration for each participant is approximately 70 days which includes a 45 day screening period.

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: TEV-56286 Test; Drug: TEV-56286 Reference

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miramar, Florida, United States, 33025
      • Teva Investigational Site 12141

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Body mass index (BMI) between 18.5 kg/m2 to 32.0 kg/m2 (inclusive)
• Females of childbearing potential agree to take appropriate measures to prevent pregnancy during the study
• Males who do not have a documented vasectomy or are not congenitally sterile must agree to abstinence or use of barrier method with spermicide with female partner. Male participant who is having sexual intercourse with a woman of childbearing potential who is not currently pregnant will be advised of her requirement to use an additional highly effective contraceptive method
• NOTE - Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

• Participation in another clinical trial simultaneously
• Females who are lactating, breastfeeding, or intends to become pregnant over the course of the study
• History of alcohol, drug or any other substance, abuse, addiction or dependence in the last 12 months (except for caffeine)
• Major trauma or surgery in the 2 months before screening or at any time between screening and the first dose of IMP, or surgery scheduled during the study or follow-up period
• Donated blood or blood products (eg, white blood cells [WBCs], platelets, etc.) within the 60 days before screening, or has donated blood or blood products at least twice within the 6 months before screening, or has donated plasma within 7 days of the screening visit or has received blood or blood products in the 6 weeks before screening
• 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, or previous personal treatment for high blood pressure
• NOTE - Additional criteria apply, please contact the investigator for more information

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; Random sequence of test and reference formulations	Drug: TEV-56286 Test; Administered orally; Other Names: Emrusolmin; Drug: TEV-56286 Reference; Administered orally; Other Names: Emrusolmin
Experimental: Cohort 2; Random sequence of test and reference formulations	Drug: TEV-56286 Test; Administered orally; Other Names: Emrusolmin; Drug: TEV-56286 Reference; Administered orally; Other Names: Emrusolmin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum Observed Drug Concentration (Cmax)	Up to Day 17
Area Under the Drug Concentration-Time Curve from Time 0 to Last Measurable Drug Concentration [AUC(0-t)]	Up to Day 17
Area Under the Drug Concentration-Time Curve from Time 0 to Infinity [AUC(0-inf)]	Up to Day 17

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of participants with at least one treatment-emergent adverse event	Up to Day 26
Number of participants who did not complete the trial due to an adverse event	Up to Day 26

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2025
• Primary Completion (Actual): May 22, 2025
• Study Completion (Actual): June 2, 2025

Study Registration Dates

• First Submitted: March 28, 2025
• First Submitted That Met QC Criteria: March 28, 2025
• First Posted (Actual): April 4, 2025

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: TV56286-BA-10218

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• 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: Yes
• Studies a U.S. FDA-regulated device product: No