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OpenTrials
Completed

NCT Number: NCT06911567

A Study to Assess New Formulations of TEV-56286

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Teva Investigational Site 12141

Miramar, Florida, 33025, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TEV-56286 Test

Drug

Administered orally

Other names: Emrusolmin

TEV-56286 Reference

Drug

Administered orally

Other names: Emrusolmin

Primary outcomes

  1. Maximum Observed Drug Concentration (Cmax)

    Time frame: Up to Day 17

  2. Area Under the Drug Concentration-Time Curve from Time 0 to Last Measurable Drug Concentration [AUC(0-t)]

    Time frame: Up to Day 17

  3. Area Under the Drug Concentration-Time Curve from Time 0 to Infinity [AUC(0-inf)]

    Time frame: Up to Day 17

Secondary outcomes

  1. Number of participants with at least one treatment-emergent adverse event

    Time frame: Up to Day 26

  2. Number of participants who did not complete the trial due to an adverse event

    Time frame: Up to Day 26

Sponsors and collaborators

Lead sponsor

Teva Branded Pharmaceutical Products R&D LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 4, 2025
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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