A Study to Assess New Formulations of TEV-56286

Last updated: July 15, 2025
Sponsor: Teva Branded Pharmaceutical Products R&D LLC
Overall Status: Completed

Phase

1

Condition

N/A

Treatment

TEV-56286 Test

TEV-56286 Reference

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 Test
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

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.