Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
47 participants
INTERVENTIONAL
2025-03-10
2025-06-02
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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Cohort 1
Random sequence of test and reference formulations
TEV-56286 Test
Administered orally
TEV-56286 Reference
Administered orally
Cohort 2
Random sequence of test and reference formulations
TEV-56286 Test
Administered orally
TEV-56286 Reference
Administered orally
Interventions
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TEV-56286 Test
Administered orally
TEV-56286 Reference
Administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
Yes
Sponsors
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Teva Branded Pharmaceutical Products R&D LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Teva Medical Expert, MD
Role: STUDY_DIRECTOR
Teva Branded Pharmaceutical Products R&D LLC
Locations
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Teva Investigational Site 12141
Miramar, Florida, United States
Countries
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Other Identifiers
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TV56286-BA-10218
Identifier Type: -
Identifier Source: org_study_id
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