Assessing new formulations of TEV-56286 in healthy adults

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

This study is testing new versions of the TEV-56286 medication in healthy adults to see how well their bodies absorb it and to check if it's safe to use.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. (industry)
• Locations: 1 site (Miramar, Florida)
• Trial ID: NCT06911567 on ClinicalTrials.gov

What this trial studies

This study evaluates the bioavailability of new formulations of TEV-56286 compared to a reference product in healthy adult participants. The primary goal is to determine how well the test formulations are absorbed in the body. Additionally, the study will assess the safety and tolerability of TEV-56286 over a planned duration of approximately 70 days, which includes a 45-day screening period. Participants will receive either the test or reference formulation during the study.

Who should consider this trial

Good fit: Ideal candidates are healthy adults with a BMI between 18.5 and 32.0 kg/m2.

Not a fit: Patients who are pregnant, breastfeeding, or have a history of substance abuse may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved formulations of TEV-56286 that enhance patient outcomes.

How similar studies have performed: Other studies assessing bioavailability of drug formulations have shown success, indicating this approach is well-established.

Eligibility criteria

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

Where this trial is running

Miramar, Florida

• Teva Investigational Site 12141 — Miramar, Florida, United States (RECRUITING)

Study contacts

• Study coordinator: Teva U.S. Medical Information

Conditions: Healthy Participants