A Study to Assess New Formulations of TEV-56286

Last updated: January 14, 2026
Sponsor: Teva Branded Pharmaceutical Products R&D LLC
Overall Status: Completed

Phase

1

Condition

N/A

Treatment

TEV-56286 Reference

TEV-56286 Test

Clinical Study ID

NCT06911567
TV56286-BA-10218
  • Ages 18-60
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 preventpregnancy during the study

  • Males who do not have a documented vasectomy or are not congenitally sterile mustagree to abstinence or use of barrier method with spermicide with female partner.Male participant who is having sexual intercourse with a woman of childbearingpotential who is not currently pregnant will be advised of her requirement to use anadditional highly effective contraceptive method

  • NOTE - Additional criteria apply, please contact the investigator for moreinformation

Exclusion

Exclusion Criteria:

  • Participation in another clinical trial simultaneously

  • Females who are lactating, breastfeeding, or intends to become pregnant over thecourse of the study

  • History of alcohol, drug or any other substance, abuse, addiction or dependence inthe last 12 months (except for caffeine)

  • Major trauma or surgery in the 2 months before screening or at any time betweenscreening and the first dose of IMP, or surgery scheduled during the study orfollow-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 leasttwice within the 6 months before screening, or has donated plasma within 7 days ofthe screening visit or has received blood or blood products in the 6 weeks beforescreening

  • 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 personalhistory of syncope, or previous personal treatment for high blood pressure

  • NOTE - Additional criteria apply, please contact the investigator for moreinformation

Study Design

Total Participants: 47
Treatment Group(s): 2
Primary Treatment: TEV-56286 Reference
Phase: 1
Study Start date:
March 10, 2025
Estimated Completion Date:
June 02, 2025

Connect with a study center

  • Teva Investigational Site 12141

    Miramar, Florida 33025
    United States

    Site Not Available

  • Teva Investigational Site 12141

    Miramar 4164601, Florida 4155751 33025
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.