A Study to Assess New Formulations of TEV-56286

Teva Branded Pharmaceutical Products R&D LLC

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: TEV-56286 Reference; Drug: TEV-56286 Test

Study type: Interventional

Funder types: Industry

Identifiers

NCT06911567

TV56286-BA-10218

Details and patient eligibility

About

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.

Enrollment: 47 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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47 participants in 2 patient groups

Cohort 1

Experimental group

Description:

Random sequence of test and reference formulations

Treatment:

Drug: TEV-56286 Test

Drug: TEV-56286 Reference

Cohort 2

Experimental group

Description:

Random sequence of test and reference formulations

Treatment:

Drug: TEV-56286 Test

Drug: TEV-56286 Reference