A Study to Assess New Formulations of TEV-56286

NCT06911567 | Completed Phase 1 FDA Drug

• 1 other identifier: TV56286-BA-10218
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• 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

Study Arms (2)

Cohort 1

EXPERIMENTAL

Random sequence of test and reference formulations

Drug: TEV-56286 Test; Drug: TEV-56286 Reference

Cohort 2

EXPERIMENTAL

Random sequence of test and reference formulations

Drug: TEV-56286 Test; Drug: TEV-56286 Reference

Interventions

TEV-56286 Test DRUG

Administered orally

Also known as: Emrusolmin

Cohort 1; Cohort 2

TEV-56286 Reference DRUG

Administered orally

Also known as: Emrusolmin

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D LLC: lead

Study Sites (1)

Teva Investigational Site 12141

Miramar, Florida, 33025, United States

Location

Study Officials

• Teva Medical Expert, MD

  Teva Branded Pharmaceutical Products R&D LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2025
• First Posted: April 4, 2025
• Study Start: March 10, 2025
• Primary Completion: May 22, 2025
• Study Completion: June 2, 2025
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)