Status:
COMPLETED
A Study to Assess New Formulations of TEV-56286
Lead Sponsor:
Teva Branded Pharmaceutical Products R&D LLC
Conditions:
Healthy Participants
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
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 object...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 2 2025
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT06911567
Start Date
March 10 2025
End Date
June 2 2025
Last Update
July 16 2025
Active Locations (1)
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1
Teva Investigational Site 12141
Miramar, Florida, United States, 33025